Iatrogenic Harm in Healthcare and the Need for Systemic Change

Paul L. Reller L.Ac. / Last Updated: August 03, 2017

Official estimates of deaths in the United States of America from medical mistakes and standard care:

In September of 2013, the website ProPublica / Journalism in the Public Interest, released a courageous article by Marshall Allen, a young journalist specializing in healthcare issues who won the 2011 Harvard Kennedy School's 2011 Goldsmith Prize for Investigative Reporting, and came in as a finalist for the Pulitzer Prize. Mr. Allen had already been recognized in 2009 by the Association of Healthcare Journalists as the best healthcare journalist in the country, and prior to this career earned a Master's Degree in Theology and spent 5 years as a minister, with 3 years spent in a ministry in Nairobi, Kenya. In this first of an ongoing series of articles on the alarming rate of medical mistakes, most of which are preventable, in U.S. Hospitals, and iatrogenic deaths and injuries in healthcare, Mr. Allen outlines the last 15 years of data reporting on this important subject, and the need for a better system of healthcare. A link to this article is provided below in additional information. The tactic of presenting the healthcare successes in hospital care, which are remarkable, to silence any criticism of the system, may not work with the level of iatrogenic harm we are seeing today.

The pioneering specialist in hospital care and evidence-based medicine, Florence Nightingale, wrote in her famous guide to hospital design, Notes on Hospitals: "It may seem a strange principle to enunciate as the very first requirement in a hospital that it should do the sick no harm. It is quite necessary, nevertheless, to lay down such a principle, because the actual mortality in hospitals, especially in those of large crowded cities, is very much higher than any calculation founded on the mortality of the same class of diseases among patients treated out of the hospital." This dictate still applies to hospitals and clinics today. Contrary to popular historical caricature, Florence Nightingale was not a simple nurse who was only concerned with dirty linens and hand washing. She was concerned with the holistic environment of healing, with attention to patient diet, activity, and psychological health, as well as the attitudes of the doctors, nurses and staff. She wrote that "to the superficial observer there are two things only apparent - the disease and the remedial treatment", but in reality, she stated, a host of factors are important for the successful outcome in hospital care. Her research in 1850 has been distorted, and the lessons have not been learned, even 160 years later.

The medical community in the United States of America has been loathe to address the issues of iatrogenic harm in the medical profession, citing the danger of deterring patients from seeking needed medical care. Like all issues, though, this one is not binary, or right or wrong in a simple sense. It is an issue that is nuanced and complex, like most serious health issues. By treating this issue as if it is a forbidden topic, we have encouraged an unspoken and ignored systemic risk that is unacceptable in standard medicine, and an attitude that is almost religious in its scope, that allows good medical doctors to accept increasingly dangerous practices in standard healthcare without a full and conscious regard for risk versus benefit.

In fact, the paradigm may have shifted again, as it has in the past, from a concept of risk versus benefit, to a concept of harm versus benefit. This situation does not benefit the patients or the doctors, though, only the companies that produce pharmaceutical medications with an increasing list of adverse effects, medical device and testing device companies with more complex machines designed to achieve results without sufficient regard to the adverse outcomes that may occur, and ever larger companies and corporations that control the hospital system, mostly with a fake non-profit status. By largely ignoring the risk versus benefit equation, and leaving much of the risk part of the equation as an unspoken taboo, we have promoted a type of technological development that has also ignored much of the risk part of the equation. By focusing on this problem, even though we would rather keep the blinders on, we will get our young researchers focused on new technology that is much safer, and hospitals that will adopt medical protocols that dramatically reduce what we now euphemistically call mistakes. The public must be aware that the issue is not one of condemning our good doctors, who are working hard to fix difficult health problems, but of creating an environment of safer overall medical care. Of course, part of this equation is the adoption of the safest medical specialty in world history, Traditional Chinese Medical Science, which is typically dumbed down by standard medicine to the word acupuncture, and has been fought and vilified for decades. Preventive medicine, and greater adoption of conservative first-line Complementary Medicine, keeps more patients from the health risks seen in our hospitals and from our newer pharmaceuticals.

Marshall Allen reveals in the first of his series of articles on medical "mistakes" that the first comprehensive report on this subject did not occur until 1999, when the U.S. Institute of Medicine (National Academy of Sciences) published a report that was given the nickname "To Err is Human". In this report, the Institute reported that by 1999 up to 98,000 people per year died due to reported mistakes in U.S. hospitals. That number was disputed both ways by public health experts and standard medicine, but is now widely accepted as conservatively real. In 2010, the Office of the Inspector General for Health and Human Services of the federal government stated that deaths from medical errors in U.S. hospitals contributed significantly to the deaths of 180,000 Medicare patients alone. By 2013, a comprehensive study in the Journal of Patient Safety reported that between 210,000 and 440,000 patients in the U.S. each year die from normal medical care that is preventable. This means that up to 440,000 patients, in a conservative estimate, die of just the medical mistakes that are preventable. The actual number of such iatrogenic deaths, many of which may be very difficult to prevent in the current system, is much higher, and when combined with the growing number of iatrogenic deaths outside the hospital, mostly from medication overdose or harmful combinations of pharmaceutical drugs, almost all of which is unintentional, the estimates of total iatrogenic deaths makes this the number one cause of death in the United States. While this has been portrayed as a political battle between standard care and its critics, it is hard to find these critics of standard care. Everyone largely supports standard medicine, an important part of our society. The real issue, as pointed out by Marhall Allen, a former minister, and a compassionate and conservative voice, is that it is time to acknowledge the problem and institute systemic change.

This 2013 study published in the Journal of Patient Safety was conducted by John T. James, a toxicologist at NASA, working at the space center in Houston, who also runs a patient advocacy organization called Patient Safety America, and became interested in this subject when his 19-year old son died from what he terms negligent hospital care in a Texas hospital in 2002. Mr. James, a renowned scientist, concluded that the system of healthcare fosters unethical and often careless patient care, and this problem is not being addressed. While we tout our superior technology in the United States, the World Health Organization ranks the U.S. 42nd in the world in infant mortality rates, and our overall life expectancy is now ranked below 40th in the world by all organizations that do such ranking, despite the per capita cost of healthcare that is twice to triple that of most comparable developed nations. Our response to this problem has been "Tort Reform", limiting the ability of patients to sue for medical malpractice, which further promotes a systemic ignoring of the problem. While there has been much reporting of expensive efforts to try to decrease rates of patient mortality from preventable hospital practices, these efforts have been largely failures so far. Typically, we still hear the same supposed solutions of more hand-washing and hygiene that were touted in 1940, but little in this proposed overhaul of patient safety of how we largely ignore risk versus benefit in patient care design. How to regain a system of healthcare that was once the envy of the world, accessible, affordable, with the latest technology, and the best outcomes, is first rooted in the acknowledgement of harm where it really is not intended.

A 2015 follow-up to the U.S. Institute of Medicine and National Academies of Sciences 2000 report on iatrogenic harm, To Err Is Human, this time given a less cynical name, Improving Diagnosis in Health Care, reported that most patients in the United States would experience at least one wrong diagnosis in their lifetime, often with devastating consequences. This committee determined from postmortem reports spanning decades that misdiagnosis contributed to approximately 10 percent of patient deaths. While most of us believe that our Medical Doctor could not be wrong in the diagnosis, it appears from this report that the standard education in the diagnostic process, the lack of teamwork, the medical system itself, especially with time-limited patient visits, keeping patients uninformed and not involved in the diagnostic process, and the insurance payment and approval system all contribute to misdiagnosis, and the situation is expected to get worse. Diagnostic errors, often spurred by the lack of time devoted to each patient visit, or the denial of approval by the insurer for a test, are perhaps the biggest concern in this scenario, but medication errors, with improper dosage, confusion with the many names of medications, improper route of administration, and lack of patient understanding and instruction with their drugs is perhaps an even bigger concern, and even more preventable. Often, the prescribing doctor is unaware of the other drugs that the patient is currently taking, and as the number of prescriptions for the individual patient increases, the lack of attention to contraindications increases as well. Patients are rarely instructed sufficiently regarding potential hazards of the drugs, problems with combining prescription medications with other prescription medications, and the dangers of too frequent use of medications that may accumulate to a toxic level. This is especially apparent with pain medications, steroids, and asthma medications. Increasing incidence of antibiotic-resistant bacterial infections, and the dogged misperception that handwashing will prevent the spread of infection, when this is failing, is fast becoming our biggest threat, though, and the notion that we need to strengthen the immune systems of the patients to truly resist this fast-growing threat is strongly resisted. The findings in recent years that a healthier gut Biome is remarkably effective to decrease hospital harm and death from pathogens proves that strengthening the immune system works. We see a large number of factors in our health care design and administration that need to be addressed systemically, including the fact that the diagnostic code is often chosen to achieve payment in this complex system, not because it is the correct diagnosis. For individuals working for insurance and government health administration such behavior stems from rules and monetary concerns, just business, and most of these workers fail to see the harm that the wrong diagnostic code can create. A more honest and ethical system is sorely needed.

In 2016, a study from the esteemed Johns Hopkins Medical School finally acknowledged that medical errors alone are now the third-leading cause of death in the United States, hidden from view by a medical tracking system that forbids this designation. The lead researcher on this study, Dr. Martin Makary, called for changes in the recording of causes of death on death certificates that would finally acknowledge this fact, with the U.S. CDC finally adding medical errors to the its annual recording of the top causes of death as well. This study conservatively estimated that more than 250,000 patients die each year from medical errors in the United States, ranking this category just behind cancer and heart disease as the major causes of death, and that this will not be reduced until we actually acknowledge the problem officially. Dr. Makary stated in an NPR interview that: "You have this overappreciation and overestimate of things like cardiovascular disease, and a vast underrecognition of the place of medical care as the cause of death. That informs all our national health priorities and our research grants." This study showed that the approach to recording mortality statistics in the United States, counting only the "underlying cause of death" as defined strictly by the condition that prompted the patient to seek medical care, or what he was being treated for, was consistent with international guidelines, and that the problem needs to be addressed in standard medicine globally. Dr. Makary also stated that the solution also involves a more proactive and informed public and patient population. Part of this solution is to promote better health maintenance and real preventive medicine, finally utilizing the resources of Complementary and Integrative Medicine and Traditional Chinese Medicine (CIM/TCM), which has long provided the holistic approach necessary to truly prevent disease before it happens, and the time-intensive and proactive patient-centered approach with providing healthy individualized professional advice to each patient to prevent and treat disease progression through better diet and lifestyle protocols. Failure to acknowledge medical errors as a cause of death creates a system that fails to research ways to decrease medical error and risk, and fails to provide patients with the facts they desperately need to know to protect loved ones and make the right choices in healthcare.

Medical errors and misdiagnosis are not the only serious concerns today, though. In the United States, the Centers for Disease Control and Prevention (CDC) estimated that 1.7 million cases of healthcare-associated infections (HAI) occurred in hospitals in 2002, which resulted in records of 155,668 deaths, with 98,987 caused by or highly associated with the infection. The CDC noted that these estimates were made with significant limitations, using old data from a hospital survey, and infection rates. The authors suggested that this 2002 report thus significantly underestimated the actual number of cases and deaths. The study of patient death records is difficult, as the cause of death is often uncertain, and a reluctance to attribute the death to a hospital infection when other co-morbid conditions could be the cause of death is well known and accepted in public health. By 2012, the U.S. CDC, AHRQ, and U.S. Department of Health and Human Services released a report on healthcare-associated infections (HAI) that showed little progress, focusing on the a coordination of efforts, research, and a foundation, at last, for HAI Data Integration and Interoperability. In other words, a healthcare-associated infection initiative had been finally established in 2008, and a plan finally published to decrease these infections in 2009. This U.S. Department of Health and Human Services Action Plan announced that "about one in every 20 inpatients has an infection related to their hospital care, and HAIs continue to take a significant toll on human life". The good news is that in the United States we can now finally define infections as "unacceptable" and can "foresee their elimination". This rosy scenario is not very reassuring to patients. Thankfully, the government finally sees hospital infections causing over 100,000 deaths per year unacceptable. Acknowledging this fact in the 1970s when esteemed medical institutions first brought up the devastating consequences of over-prescription and unnecessary and useless lengths of treatment courses with antibiotics, creating a future antibiotic-resistance that would create an enormous public health threat would have been much more reassuring. Stopping the practice of widespread use of antibiotics just to spur fast growth in feed animals in the 1980s would have been much more reassuring.

To put this number of deaths documented yearly that are attributed to just infections acquired in the hospital setting, not the total deaths attributed to infections, mistakes and normal medical treatment, we should compare this to data from the U.S. Centers for Disease Control and Prevention (CDC) concerning the total yearly deaths attributed to injuries. In 2005, the U.S. CDC reported that poisoning deaths surpassed deaths from firearms for the first time since these were recorded, and were approaching the total number of yearly deaths from the leading cause of injury-related death, motor vehicle accidents. The yearly number of poisoning deaths in the U.S., 91 percent of which were caused by unintentional drug-related causes, totaled 32,691 in 2005. The vast majority of these were related to pharmaceutical drugs, not heroin overdoses, which typically cause a few thousand deaths per year, and are overshadowed by the number of overdose deaths from use of narcotic pain medication. Even heroin overdoses, rising again in recent years as the flood of heroin from the U.S. occupied country of Afghanistan finally reaches our shores, are now increased because many young users easily find the newest synthetic narcotic, fentanyl, available and combine it with poor quality heroin to get a better high. Fentanyl, which is not a very good pain reliever, is especially dangerous with potential overdosing. To increase the narcotic high, drug dealers are purchasing this pharmaceutical drug and just adding it to heroin without telling the buyer, despite the fact that fentanyl is not sold as a pill, only a topical patch or a lollipop (yes, a dangerous narcotic drug is sold as a lollipop). Despite these facts, the subject of heroin overdoses is heavily reported and discussed in legislative hearings, yet the subject of pharmaceutical deaths is hardly mentioned. Comparative statistics for these causes of death overall are very hard to find, as such comparative analysis would provoke alarm. We are also stubbornly ignoring the large number of deaths resulting from drug-drug interactions and combinations of pharmaceuticals that may cause death. The result is that there is a systemic lack of concern for the rising numbers of iatrogenic deaths.

Two mounting problems with healthcare-associated infections are very alarming. In some studies, the percentage of antibiotic-resistant strains of bacteria causing hospital infections has risen to 60 percent in many hospitals. This is due to a persistent overprescription, and prescription of an unnecessary and useless prolonged courses, of antibiotics, for decades after research noted that this was a dangerous practice. We knew decades ago that there was little hope of developing ever new types of antibiotics. By a blind and religious adherence to treatment guidelines that were largely written by the same industry that sold the drugs, we ignored common sense and scientific wisdom, and in fact increased prescription of antibiotics when this practice was criticized. Despite scientific proof of efficacy of herbal medicine to treat many less threatening infections, to enhance the effects of antibiotics to decrease the need for dosage and long course of therapy, and more importantly to treat viral and other microbial infections at an early stage instead of just prescribing antibiotics, the use of herbal medicine was highly discouraged in standard medicine. An almost religious zeal to stop the use of benign herbal medicines occurred, and this was not based in fact or evidence of harm. We see that the motivations concerned profit and competition.

We are now paying the price. This cavalier attitude has also led to the widespread use of antibiotics to promote faster growth in industrial feedlots, a topic still largely ignored by the community. Secondly, rates of hospital-acquired severe diarrhea from antibiotic-resistant Clostridium difficile, and hospital-acquired pneumonia that is resistant to treatment, are creating historic highs of deaths from these diseases. In 2011, the U.S. Centers for Disease Control and Prevention estimated that at least 14,000 Americans died in hospitals from Clostridium difficile infection and severe diarrhea in one year. This is just from one of the common bacteria that cause gastrointestinal dysentery in the hospital. In 2006, 55,477 people officially died of pneumonia, but it is unclear what percentage of these were due to antibiotic-resistant strains of bacteria, and many more older patients may have died of hospital-acquired pneumonia and had the cause of death listed instead as the disease or injury that they came to the hospital to treat. The U.S. CDC estimated that in 2002, 35,967 patients died of hospital-acquired pneumonia. We do know that approximately half of pneumonia cases are believed to be caused by viruses, yet almost all cases of pneumonia in the hospital are treated with antibiotics. We also see a global spread of previously rare infections that show a pan drug resistance, or resistance to all antibiotics, antimicrobials, and disinfectants, such as Acinetobacter baumannii, and the increasing global incidence in intensive care units, where environmental hygiene, handwashing, and other precautions are the most intense. Despite this, the emphasis remains on hand-washing and environmental disinfection, not the strengthening of host immune defenses. As Florence Nightingale duly noted, most infection occurs naturally from viruses and microbes carried in the air we breath, and in a hospital, this air may become overly concentrated with such virulence, requiring sufficient flow of fresh air into the space. The mechanical sanitation of the air will not kill viruses, as they are not living organisms, and are too small to filter. Our current hospital design with sealed windows results in a concentration of the viruses, and the most minute microbes, that are breathed into the air or stirred up by activity from the skin of sick patients. Her second point was the importance of maintaining the immune health of the patient, and sufficient exposure to sunlight, generating enough hormone Vitamin D, melanin, etc., as well as a more healthy diet than normal, are two basic concerns. These continue to be overlooked in the system, as hospital design is dominated by ease of delivering more and more expensive treatments, and the profit motive.

By 2016, another emerging problem related to standard medical care, overprescription of drugs to treat anxiety and pain, had become evident. A study at the Albert Einstein College of Medicine in New York, New York, U.S.A. headed by Dr. Marcus Bachhuber and printed in The American Journal of Public Health found that despite the risks and warnings of benzodiazepine dependence, withdrawal and rebound syndromes, and adverse health effects with chronic use, that prescriptions for these drugs rose 67 percent between 1996 and 2013, and that the rate of overdose deaths with benzodiazepines rose more than fourfold, to 3.07 per 100,000 adults in 2013. The rate of overdose deaths from opioid pain medications, considered an epidemic now, was 6.8 per 100,000 for non-Hispanic white persons, and for Black and Hispanic individuals in the United States was now 2.5 per 100,000. The U.S. Centers for Disease Control and Prevention reported that in 2014, 44 people die of the result of prescription opioid overdose every day. The present statistics for such cause of death from the many now addicted to benzodiazepines is thus about 20 people per day, yet this statistic is largely ignored. As these alarming statistics of death from our healthcare system grow, we here nothing more than the same labeling of heroin overdoses and addiction to divert attention from this iatrogenic harm to public health. Medical Doctors and patients continue to take benzodiazepines for anxiety and sleep without thought of the consequences. To see this study of benzodiazepine overdose deaths, click here: http://www.einstein.yu.edu/news/releases/1155/overdose-deaths-from-common-sedatives-have-surged-new-study-finds/ . To see the report in comparison of opioid medication overdose deaths from the U.S. CDC, click here: http://www.cdc.gov/drugoverdose/data/overdose.html . The time has come to start using Complementary and Integrative Medicine and Traditional Chinese Medicine (CIM/TCM) to treat anxiety, insomnia and pain, resolving underlying health causes, and to decrease the enormous public health problems with these drugs.

Overall, in 2013, we are finally acknowledging what some public health experts have been noting for well over a decade, and vilified for their efforts, that the combined account of deaths from medical error, healthcare-acquired infections, antibiotic-resistant strains of bacteria, and medication, or iatrogenic causes, is now the number one cause of death in the United States. This also implies that the incidence and account of injury and disease not resulting in death is also enormous from iatrogenic causes. While we must acknowledge that some harm is expected from allopathic treatment of difficult and threatening health problems, this level of collateral damage is unacceptable, and can be reduced dramatically. We can and must continue to provide the best healthcare possible, but not by incorporating unacceptable risk and consequence into the equation of success. The first step in reduction of iatrogenic harm is to better utilize and integrate health care that causes no harm and prevents more dangerous disease and injury from occurring. The second step is to adopt a fundamental resolve to incorporate less risk into the healthcare technology and the delivery system as a basic principle. Fewer adverse effects must be achieved in the design of new drugs, in the design of new medical devices and technology, and in the design of hospital care. Cutting nursing staff and pay, rather than the wasteful spending and ancillary profits in the healthcare system, needs to stop. Continuing to demand up to 80-hour work weeks for young medical doctors in their internship needs to stop. Letting health management accountants and insurance companies decide what care is delivered needs to stop. The idea of profligate profits gleaned from the most desperate in our society, the sick, elderly and desperate, needs to stop. The idea that healthcare is foremost a business rather than a vocation needs to stop. A fundamental change of heart is necessary, at a subconscious and society-wide level.

The 21st century may need another Florence Nightingale, a tireless healthcare reformer who introduced standards of patient care that greatly reduced harm, who disseminated public health information so that the public could finally take a proactive approach to their safe and effective care, who taught the public that educated clinical nurses were essential to this type of healthcare, and who pioneered the use of statistics to guide healthcare design. Hopefully, this person will step up.

The Florence Nightingale Declaration Campaign, established by the Nightingale Initiative for Global Health, has established the UN Decade for a Healthy World as 2011 to 2020, and called for a rekindling of issues important to the famed healthcare reformer Florence Nightingale, especially preventive medicine and holistic healthcare. Ms. Nightingale's pioneering theories that infection spread not by direct contact alone, but was ubiquitous and spread by poor host defense, is still largely ignored in modern medical science. Contrary to historical propaganda, Florence Nightingale did not insist that sanitation of the hospital environment alone decreased the death rate, but that effective nutrition, preventive health measures, restoring the depleted health of the patient, and creating a positive environment, were primary concerns. This holistic approach to health and healthcare outcomes has been fought since her death in 1857, but we may finally see a sea change.

Strategies for Protection against healthcare-related illness, injury and death, or iatrogenic injury and death

While we patiently wait for the healthcare industry to reduce the 1 in 20 infection rate for hospital care patients, with up to 60 percent of these antibiotic-resistant, and rising risk of severe diarrhea and pneumonia, the patient population is looking for pro-active strategies to protect themselves. Of course, avoiding all hospital visits is a ridiculous strategy, as medical care is absolutely necessary to save lives and fix problems. What we can do is 1) utilize hospital care only when necessary, 2) adopt strategies with probiotics and strengthening of immune protections before entering the hospital, and 3) integrate more preventive and benign therapies into treatment at the first signs of trouble. In this regard Complementary and Integrative Medicine and Traditional Chinese Medicine (CIM/TCM) are ideal. Ignoring health problems until they are severe is obviously childish, yet this is what we have been led to accept as the correct attitude. One reason for this is that our hospital care, and standard medical care in general, is designed to deal with our health problems when they are more severe, not in the early stages, and the concepts of what we call preventive medicine in standard medicine are often ridiculous, designed purely to detect a higher percentage of patients with severe problems before the disease is so far advanced that there is little left for us to do. Often, these weak strategies of prevention are used to generate more patients that may receive harsh and risky treatments that are unnecessary. The logic that it is a good idea to prescribe potentially harmful treatment to 100 patients because one of them may benefit in the long run has been strongly criticized by public health experts in recent years.

A more holistic diagnostic approach is sorely needed, and early diagnosis of risk, with promotion of benign treatments by integrating Complementary Medicine is a safe and conservative approach, not an alternative. By actually integrating Complementary Medicine into the patient care, rather than pretending to integrate, medical doctors will see that the rewards are evident. Better outcomes, true prevention, and better quality of life will create an incentive for patients to utilize the medical doctor that truly integrates Complementary Medicine.

The propaganda that Complementary Medicine is a competitive specialty that will hurt the profession of the medical doctor is not true, yet this attitude still prevails. Lip service is seen more and more as the evidence for effectiveness becomes overwhelming, but one must walk the walk, not just talk the talk. Strategies to utilize ineffective protocols of Complementary Medicine are now widely seen in standard practice. Hospitals with Complementary and Alternative Medicine (CAM) clinics control the standard of care and stress light massage and spa-like medical treatment instead of the type of Complementary and Integrative Medicine (CIM) seen in Chinese hospitals, where large professional herbal pharmacies, and physicians that are highly trained in acupuncture and physiotherapy, as well as herbal prescription, are given free reign to utilize the most effective treatment protocols and strategies. This type of integrative approach is now widely seen in hospitals in all of Asia as well as Australia. In the United States, Licensed Acupuncturists are hired and given strict restrictions on their care delivery, with too little time spent, acupuncture approved for a very limited array of health problems, sometimes restrictions on the points used, and courses of therapy that are too short or infrequent. The Licensed Acupuncturist employed in the U.S. hospital system is also not allowed to prescribe herbal and nutrient medicine, even though the bulk of their medical school training involved this specialty protocol. Medical Doctors often prescribe herbal and nutrient medicine even though they receive virtually no medical school training in these sciences, and often perform acupuncture, with virtually no requirement that they receive any training in this field. To be certified to practice acupuncture, the Medical Doctor only has to take a 60-hour video instruction in most states. The end result has been a limitation on effectiveness of acupuncture and TCM (Traditional Chinese Medicine) by design. Large studies in recent years in the U.S. and Europe found that even minimal instruction in nutritional medicine is lacking in a large percentage of University Medical Schools, with only about a fourth of these standard medical schools meeting the minimal number of hours of instruction recommended by the National Academy of Sciences. Of course, instruction in herbal chemistry and medical care is completely absent, yet most medical doctors receive much propaganda paid for by the pharmaceutical industry concerning the potential of negative herb-drug interactions, despite the complete lack of clinical proof of this happening.

How important is the integration of Complementary Medicine and true preventive medicine? Take for example the case of healthcare-related infections, or nosocomial infections (hospital-related). The U.S. AHRQ (Association for Healthcare Research and Quality), an agency of the U.S. Department of Health and Human Services, estimates that these infections, acquired more than 48 hours after admission to a hospital, occur in approximately 5 percent of all U.S. hospital patients, and more than double the risk of mortality or morbidity, increasing the costs of hospital care dramatically ($35-39,000 per case in the event of methicillin-resistant Staphylococcus, MRSA, or bloodstream infections), and are increasing in incidence. AHRQ estimates from studies that at least 60 percent of these infections relate to bacteria that have already colonized the patient's digestive tract prior to admission. This means that the problem lies in the patient's ability to control bacterial colonization and overgrowth when faced with the stress of a hospital stay. Eradication of bacteria prior to hospitalization with antibiotics is not an answer, as this not only depletes the intestinal biota of the patient, and their gut membrane immune capability, but also creates more antibiotic resistant strains and an imbalance of gram negative and gram positive bacterial strains, which need to be in balance to protect the host. In other words, the patients need to have a healthy microbial biota and gut immune function prior to hospitalization to effectively decrease nosocomial infections and mortality/morbidity.

The specialty of Traditional Chinese Medicine (TCM) achieves this goal of strengthening the immune system and regaining a healthy balance in the gut Biome prior to hospital care. Simple taking of probiotics alone is shown to be ineffective to suppress the occurrence of Clostridium difficile-associated infection, but an 8 day course of antibiotics, use of medications to treat acid regurgitation or other stomach problems (proton pump inhibitors or histamine type 2 blockers), and intravenous hyperalimentation (IV nutrition) all were associated with increased risk of this infection (Mizui T, Pharmacie 2013, Aug; 68(8): 706-10). Since these infections are not the result of bacteria in the hospital environment, increased hand-washing and better laundry methods of disinfection will not stop the endogenous overgrowth of bacteria already within the host patient. This will only stop those infections acquired from the hospital environment, not in the environment of the patient's body. A more thorough and holistic approach to gut immune health and immune function is needed to prevent these infections. To continue to pretend otherwise for another decade or two may be a ticket for disaster.

The most common healthcare-associated infections are urinary tract and lung infections. Here too, the majority of cases may be associated with bacteria already in the patient, not introduced via sterile urinary catheters and ventilation tubes. In fact, studies clearly show that patients reduce risk of pneumonia and recover faster when they are more active and perform deep breathing, showing that healthy function of the lungs and respiratory tract increase the innate immune protection and work better than anything to prevent these healthcare-related infections. If the patient had a healthier immune function and respiratory health prior to hospitalization, and was more informed and motivated to maintain this while in the hospital, rather than just resting in bed and breathing shallowly, hoping that if infection occurred, that the hospital would just provide an antibiotic to clear it without any healthy effort, the problems of healthcare-associated pneumonia would be greatly reduced. As an individual that worked in a large hospital in nursing and took care of patients with pneumonia, I can assure you, as can many nurses and respiratory therapists, that frequent activity, deep breathing and coughing, and clapping, or percussion, on the back over the lungs, works much better than antibiotics to clear pneumonia. In Chinese hospitals, evidence-based use of Chinese herbal medicine to enhance the action of antibiotics, especially with antibiotic resistance, has proven very effective. Treatment prior to hospitalization with acupuncture and herbal medicine may significantly improve the host defenses and membrane health. In addition, TCM provides the patient with greater incentive to take a more proactive role in healthcare. Greater use of the PPSV pneumococcal pneumonia vaccine for bacterial pneumonia may be helpful as well, although the vaccine has been found effective in approximately 60 percent of those treated, and is much less effective in patients with a compromised immune function. Problems with study design have called into question even this efficacy, as well as the lack of clinical trials in the targeted population over age 65, and the finding of vaccine hyporesponsiveness with follow-up vaccination. The immune antibody effects decrease over time for the PPSV to a level below pre-vaccination state by 5 years, and of course, this vaccine dos not protect against viral pneumonia or other types of bacteral pneumonia. There is no 'alternative' to the innate natural immune protections in the human organism, and traditional holistic medicine works by enhancing and stimulating these immune responses. As research progresses, we find more and more evidence supporting specific protocols in Traditional Chinese Medicine (CIM/TCM), but almost no integration of this specialty to help prevent healthcare-associated infections, or recover from healthcare-associated morbidities.

The most glaring examples of misdirected medical care and under-utilization of Complementary and Integrative Medicine (CIM) resulting in healthcare-acquired infections concerns the over-prescription of antibiotics and acid-reducing pharmaceuticals. Numerous studies (a meta-review is cited below with a link in Additional Information) now show that the prescription of a proton-pump inhibiting drug, such as Nexium, Protonix et al, increases the risk for hospital-acquired pneumonia and diarrheal dysentery from Clostridium difficile dramatically, more than doubling the risk in many studies, resulting in many thousands of deaths, which are increasing yearly. This is due to the fact that by inhibiting gastric function a cascade of events occurs which hurt the natural gut immune functions. Utilizing Complementary Medicine to instead restore gastrointestinal function could thus save your life someday, besides saving you money, and improving your overall health. The second persistent misdirected medical care that seemingly will not stop despite, or perhaps in reaction to, the decades of scientific information that shows the inherent danger in the practice, is the over-prescription of antibiotics. This issue cannot be dumbed down to a simple right or wrong, yes or no, in antibiotic prescription, but needs to be the realm of intelligent decision making of the prescribing doctor. Instead, the decrease in antibiotic prescription is coming from public health experts and the patients themselves. The fact that this is utterly ridiculous and creates an enormous amount of iatrogenic harm seemingly is beyond the comprehension of most Medical Doctors, and the general public continues to shrug their shoulders and look confused when the issue is brought up. A simplistic binary answer is too often elicited when discussing antibiotic overuse, which is not a sensible reply.

Another glaring example of the systemic problems in hospital protocol is the now common practice of corticosteroid prescription to patients with hospital-acquired infections, and patients with moderate to severe infections admitted to the hospital. Studies in recent years finally showed that this practice was at best unnecessary in most cases, and at worst actually increased the risk of death from infections. Corticosteroid medications come with a long list of warnings and adverse health effects, including immune suppression and increased risk of infection. In the past, corticosteroids were only administered when all else failed, and the equation of risk versus benefit was taken much more seriously. Slowly and insidiously, the treatment guidelines were changed over the years and doctors started routine prescription of corticosteroids. Corticosteroid prescription in the general population outside the hospital increased dramatically as well. By 2010, University health centers finally performed clinical outcome studies on these immune-suppressing corticosteroids and concluded that this now normal and frequent prescription of corticosteroids for patients with infections in hospitals was dramatically associated with increased risk of prolonged infection, death and prolonged hospital stays. So far, these studies have not resulted in any change in corticosteroid prescription at all. Studies as far back as 1994 indicated that hospital-acquired pneumonia and antibiotic-resistant infection was significantly associated with prior use of antibiotics and corticosteroids, yet the prescription of these drugs increased dramatically, rather than decreased. It appears that logic and data do not actually guide hospital policies, only the larger guidelines and protocols, which are often highly influenced by the healthcare industry and sales. The systemic problem here is blind adherence to protocols and policies and an apparent inability to see when these protocols and policies are not right.

The U.S. AHRQ states that extensive research by the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) shows that about 50 percent, or half, of antibiotics used in U.S. hospitals are inappropriate, that this contributes greatly to increasing antibiotic resistance, and the more than 70 percent of the bacteria that cause hospital-associated infections are resistant to at least one antibiotic. As more and more bacteria become multi-drug resistant, the incidence of mortality and morbidity increases dramatically. Between 1998 and 2003, the incidence of antibiotic resistance in studied hospital infections increased between 11 and 20 percent for the most common bacteria involved. Since 2003, this has increased much more than this. Ultimately, this problem will overwhelm our hospitals. Unfortunately, the answers to this problem are still the same tactics from decades ago, with a stubborn insistence that we cannot strengthen the host immune defenses, so we must resort to exogenous factors that are not bringing the success we need. This is because standard medicine does not have true preventive measures, or means to improve the host health and immune defense. Complementary Medicine does.

Strategies to reduce the rising tide of medical errors in the hospital and primary clinic have been resisted for decades. Improving diagnostic accuracy requires that the diagnostic protocol be better coordinated between specialties. In the age of specialization, the first doctor to be assigned the patient will naturally perform tests to find a cause within their specialty, often ignoring the potential in other specialties. The assigning of a clinical nursing specialist in diagnostic management would insure that the patient had the basic tests and exams needed to fully address the differential diagnosis, yet the hierarchical notions in standard medicine still prevent this simple fix from happening. Even though we now have a great percentage of Medical Doctors who are women, and a great percentage of nurses who are men, the hierarchical doctrines of the 19th century persist in preventing the overseeing of individual patient care by a team that includes a nurse. Instead of working together more efficiently, dogged determination to maintain an outdated system of medical hierarchy continues to kill an enormous number of patients. Increased dependency on technological tests alone to determine diagnosis is another area that has not been addressed sufficiently with the system. As technology improves, dependency on the reports of MRI, CT, X-ray, and blood lab tests to make the diagnosis naturally increases. The data, though, tells us that there are percentages of error, and incomplete diagnostic data, on these tests. While it is well known that test data should be used as part of the tools in overall diagnosis, increasingly, to save time and money, the diagnosis is made completely based on the test performed and the interpretation of the tests by technicians.

Less instruction in manual physical exam and interpretation of signs and symptoms within a differential diagnostic system has been emphasized in standard medical schools. This is because efficiency and need to find the greatest common denominator and one-size-fits-all treatment protocol now dominates the system. Unfortunately, the human organism is not like other manufactured products, and the array of variation and factors in human health problems is extreme. An efficient system of placing test data within the diagnostic workup, and depending more on the deductive skills of the diagnostic team is needed. This team should include an assigned diagnostic clinical nursing specialist to make sure that teamwork trumps individual hierarchy within this system. Protocols for what tests are ordered should not affected by management and commercial interests, either, and the quality of testing services and analysis should have greater oversight, and not be guided by reducing payroll costs and cost-cutting at the expense of quality and dependability. The systemic fixes in the system are nuanced, and not simple to execute, but we do know how to achieve the right goals. Unfortunately, this will take a concerted effort on the part of each person involved, not just a redesign of the hospital interior and adoption of more computer technology.

One problem with medical error that has come up time and time again is the problem of keeping track of the many names of a single drug. As one new pharmaceutical medicine is introduced, there are the multiple brand names of the manufacturers, and the technical name given to the drug itself. Often, the highest selling version gets to win the name game, and the drug is usually called this, but in the hospital, information tied to the drug is often more associated with its scientific name, not the name created purely by marketers, which now often bears little resemblance to the actual name of the drug. This problem has worsened as more drug sales depend on the enormous amount of money spent on television and media advertising. With massive increases in advertising driving patient demand, the names of the drugs had to change to make them more appealing sounding. In the hospital and clinic setting this leads to confusion, especially when two drugs with distinct differences have names that are almost the same. Examples of similar names for dissimilar drugs that cause such errors include Flomax and Volmax, Zantac and Xanax, clozapine and olanzapine, methodone and methylphenidate, Toradol and tramadol, Lexapril and Verapamil, and so on. These examples are of drug name pairs with very different drug effects for each of the drugs, and if the wrong drug is administered, the potential for harm is very real. Often, the handwriting of the prescribing doctor may not be clear, and it is up to the nurse to make important decisions when dispensing. As the nursing staff is decreased to cut costs, this problem can increase in incidence. Nurses are responsible for the correct administration of hundreds and hundreds of different drugs, and the ability to memorize the different names of each is a problem. As costs are cut, and nursing staffing, and this drug naming problem just increases, more and more mistakes are going to happen. Not only the administering of the wrong drug, but incorrect routes, such as intramuscular (IM) veruse intravenous (IV) may be unclear, and most importantly, the numerous contraindications with other drugs, either acutely or with chronic use. Use of clear computerized systems with lightweight computer pads or tablets for the nurses and doctors, as well as clinical nursing specialists that are keeping track of drug administration, potential contraindication, and even diagnostic testing protocols, and differential diagnosis, would be sensible to decrease medical errors, as well as the simplification of the drug names. The question is whether a systemic change or changes will occur that guarantees better patient safety.

Not only the problems seen in pharmaceutical guidelines, errors, and over-prescription, but problems with medical devices and a lack of safety, guidelines and regulation is becoming a big issue in modern hospital care. For instance, in 2015, the Wall Street Journal reported that the U.S. FBI revealed that an ongoing investigation is revealing that a medical surgical device called a morcellator, now widely used in noninvasive surgery, may spread cancer if the tissue being excised and removed is potentially metastatic. The device, now widely used in hysterectomy, or removal of the uterus, has rapidly spinning blades that morcellate the tissue so that it can be removed through tiny slits of a device that suctions the tissues in laparoscopy. Unfortunately, investigation has revealed that the device may spread seeds of cancerous tissue that was not detected prior to surgery. An anesthesiologist in New Jersey, Dr. Amy Reed, has reported that in 2013 she had a hysterectomy due to large fibroid tumors at the Brigham and Women's Hospital, in Boston, Massachusetts. A biopsy after the surgery noted that an aggressive type of sarcoma was encapsulated in the fibroid tumors. After the surgery, the cancer cells spread, or metastacized, resulting in stage 4 cancer. Dr. Reed and her husband, a well known physician, Dr. Homan Noorchashm, have publicly called for a ban on this device, stating that the risks were not revealed by the manufacturer. The U.S. FDA revised guidelines in November of 2013, stating that the device should no longer be used in "the vast majority" of cases, but little has changed in the field. The FBI, investigating the branch of Johnson and Johnson, Ethicon, which markets the device, found that an expert, Dr. Lamparter, revealed that he warned Ethicon of the dangers of spreading cancer with the device in 2006, and with the current investigation, Johnson and Johnson removed the device from the market. The company stated that they revised the recommendations after the 2006 warning, but Dr. Lamparter, in an New York Times interview stated that this was a "legal fig leaf", and that the use of the device had not changed. Gynecology groups have resisted the change in surgical care, stating that in their opinion, minimally invasive surgery is safer for the majority of women, and that these aggressive tumors in such tissues are rare. Such an example shows the standard systemic problem, with a complex system of denial of risk, denial of information, and denial of responsibility, as well as a hiding of the real facts of these cases. In this case, a couple that were knowledgeable physicians themselves found out what the real cause of the cancer was. Typical patients probably would never suspect.

What measures are actually being taken to insure better quality of care and reduced iatrogenic death and injury?

In December of 2011, the U.S. AHRQ (Agency for Healthcare Research and Quality), a branch of the U.S. Health and Human Services, reported that Hospital Boards had adopted new guidelines and practices to enhance oversight on quality of care and reduce mortality. These announced guidelines were "requiring major new clinical programs to meet quality-related criteria; setting some quality goals a the "theoretical ideal" level; requiring the board and the medical staff to be as involved as management in setting the agenda for discussion on quality; and requiring the hospital to issue public quality/safety performance reports." In other words, lip service. The federal government responded by creating a system of rating hospitals for their quality of care and safety, and posting this information online where it would be accessible, as well as rewarding hospitals with the best statistical quality of care and safety. Of course, this is being heavily criticized and fought. The establishment of independent medical panels to review and publish guidelines and criteria, independent of both the government and the industry, have been called "death panels". Large amounts of money have been spent on better electronic record keeping, with monetary incentives in the Affordable Care Act, yet most hospitals provide only the Medical Doctors with easy access, such as light weight electronic computer tablets and pads to access patient records to prevent errors associated with diagnostic and medication oversight. Nursing staff, critical to such monitoring, are almost always given heavy and difficult computer monitoring systems, despite the fact that their oversight of patient care is critical, and this type of electronic system may actually reduce their efficiency in patient care, as well as creating problems with repetitive and postural stress injuries.

It seems that enacting actual change in hospital protocol that is meaningful and systemic may be just as hard as it was in the 19th century for Florence Nightingale. The protocol has always been more important than the actual quality of life of the patient. The old joke in the hospital - The surgery was a great success, unfortunately the patient died - is a cruel joke, yet has always had a ring of truth. Until standard medicine adopts actual systemic changes of attitude in patient care and prescription practice we may not see significant progress on this problem that has grown in proportion until now the major cause of death in the United States is standard medical care. One significant change in attitude would be the integration of the statistically safest treatment specialty in world history, Traditional Chinese Medicine.

One important aspect of hospital safety emphasized in the first comprehensive scientific study of this subject, by Florence Nightingale, in 1850, concerns the much greater risk of iatrogenic harm and nocosomial infections in larger hospitals in urban environments. Ms. Nightingale emphasized strongly that the medical industry increases profit by bringing more and more patients to these larger urban hospitals, convincing the public that these institutions have better and more advanced medical technology, and thus will be a better bet to achieve the best results from the care. Florence Nightingale, in her unbiased scientific study of hospital care, though, showed that this was not true, and that the safest care came from smaller hospitals outside of the urban centers. She was largely ignored. Today, the situation has not changed, and it is still being ignored. In fact, as the hospital system in the United States continues to consolidate into fewer and fewer corporations, more and more small hospitals are being driven out of business, and research is showing that the public is being harmed. While there has been little incentive to research this subject and recommend to the public that it may be safer to seek care at a more conveniently located small local hospital, this is finally occurring as the public health experts are noting that the closure of so many of these small hospitals is indeed creating great statistical evidence of harm to public health. In 2014, Leapfrog and Consumer Reports listed the safety scores of thousands of hospitals in the United States, and the top score came from the tiny Miles Memorial Hospital in Damariscotta, Maine with a score of 78.

One problem for small rural hospitals is the trend in the last decade or two to pay less for care in cases of Medicare and Medicaid to these smaller urban hospitals, as a cost-cutting initiative to decrease the federal deficit. The rationale for this equation was that it cost less to deliver the care in the smaller urban communities, but many are now considering the possibility that this was arrived at via lobbying efforts by the larger hospital corporations, not by actual reality. One feature of the Affordability Care Act was a readjustment of Medicare reimbursement based on hospital safety. A July 21, 2015 news story on National Public Radio, entitled Expanding, Not Shrinking..., revealed that at least 55 small rural hospitals have closed in the United States between 2010 and 2015, with another 1 in 10 at risk of closing soon. This story highlighted one such hospital, Putnam County Memorial Hospital, in Unionville, Missouri, which was revitalized largely due to the efforts of a local cattleman, Greg Fleshman, and the local health care consultants Jerry and Cindy Cummings, of central Missouri, who designed a plan to reopen units in the hospital to provide much neglected healthcare such as psychiatric, gynecological, pediatric and cardiology care, increasing the hospital revenue quickly from $4 million to $22 million, and the daily intake of new patients to 12. By providing needed hospital care that has been downsized to support more lucrative specialties, this small hospital is providing desperately needed care to a rural population that has been forced to drive hours to receive treatment, and delivering a much safer hospital experience. Expansion of Medicare coverage and the number of individuals with health insurance has insured greater income for small rural hospitals, but these facilities must also be recognized as potentially the safest place to receive much of our healthcare, and utilized properly when appropriate. By designing our healthcare system to provide care that is appropriate to the small hospital setting we may decrease the numbers of injured patients and iatrogenic mortality considerably. This requires a concerted effort by individuals, communities, and state and federal government.

In 1975, there were 7,156 hospitals in the United States, and by 2009, despite the population increasing from 216 million to 306.8 million, the number of hospitals shrank to 5,796, and beds in hospitals shrank during this time from 1,456,828 to 944,277. Occupancy in the largest hospitals, with more than 400 beds, was considerably higher than smaller hospitals, and it was statistics like these that drove the hospital planning and availability. By 2015, some hospital systems, such as the Mount Sinai Health System in New York, associated with the Icahn School of Medicine, had fully adopted a network of hospitals serving a broad array of neighborhoods with hospitals that ranged in size from 212 to 1,171 beds. To achieve cost-cutting, most smaller hospitals have thought that the only way to survive was to join a large system, and much pressure from the hospital boards have moved them in this direction. Hospital network growth, though, can potentially drive up prices, as well as create networks that violate anti-trust laws, and some of these regional mergers are being prosecuted. The decrease in the number of hospital beds per capita, the number of hospitals per capita, the number of small hospitals in less populated areas, and the public choice in healthcare are not contributing to a safer and more equitable system. While the cost of healthcare, and the charge-to-cost ratio, is ballooning, the quality of care, and access to care, is declining. This equation is becoming alarming.

To provide for a sensible first-line healthcare system that is accessible and affordable, the Affordable Care Act provided an additional $9.5 billion to operate Community Health Centers, and an additional $1.5 billion to contribute to construction. These health centers have expended for nearly 50 years, and provide needed healthcare services and direction for low-income communities. They operate on a sliding scale fee structure and offer an array of enabling healthcare to achieve a more proactive role by the patient population. Since 2000, the number of these community healthcare clinics has soared, delivering important care and improving public health dramatically. The model for first-line community healthcare clinics, though, has been promoted for decades to serve all communities, though, by the Physicians for Social Responsibility, who have seen the success of this model in countries like Cuba, providing efficient care and direction to larger and more specialized healthcare facilities as needed. Such an expansion of conservative care and professional guidance would decrease the bureaucratic costs of our healthcare dramatically, and be able to treat disease and injury before it progresses to a more costly and threatening state. True preventive care would provide access to such care as a universal public health service, and would decrease overall healthcare expenditure by an amazing amount, as well as preventing a large percentage of our current iatrogenic harm and nocosomial infections.

Inadequate Measures to Prevent Iatrogenic Harm from Pharmaceutical Medicines is Rapidly Being Undermined Even Further, as the Public is Inundated with Advertising and Marketing Schemes that Belay Public Caution, and Medical Doctors are Slow to Object to Obvious Harm

The United States Food and Drug Administration (FDA) was created to enforce the Federal Food, Drug and Cosmetic Act of 1938, as well as Section 361 of the Public Health Service Act of 1944, which established authority to quarantine and prevent the introduction and spread of communicable disease, as well as Title X in 1970 to provide family planning services for those in need, and more recently the Patient Protection and Affordable Care Act of 2010, as well as the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. The FDA has authority to approve new drugs and their uses, regulate prescription drug advertising and promotion, and enforce these regulations. Companies may only advertise or promote a drug for the specific indications or medical uses for which it was approved, and must make clear the balance of benefits versus risks. Drugs may be prescribed by Medical Doctors for unapproved uses, but they cannot by advertised or promoted for these uses. Postmarketing safety is unfortunately monitored by voluntary reporting of adverse health effects with long term use. A long history of inadequate public and patient protection accompanies the history of the FDA, first established in 1906 as the Food and Drug Act under President Theodore Roosevelt to seize and drugs that were "adulterated" and transported over state lines, or the marketing of said "adulterated" drugs, and requiring the standard of strength, purity and quality of the active ingredients to be listed on the label. The name FDA was adopted in 1927, and by the 1930s a growing number of products legally allowed under the act prompted President Franklin Delano Roosevelt to finally sign the new Food, Drug and Cosmetic Act in 1938, after a number of new drugs and cosmetics introduced killed hundreds of unsuspecting users. Finally, a pre-market review of safety was mandated, false therapeutic claims in drug labeling were banned, and by 1951 certain drugs were specified to be available only via prescription, and enforcement of post-marketing recalls were strengthened.

In 1959, Dr. Frances Oldham Kelsey, a former family practitioner and professor from South Dakota, was appointed as the medical officer of the FDA, and one of her first tasks was to approve the drug thalidomide, or Kevadon, a sedative hypnotic marketed in Europe, Canada and Middle East to treat morning sickness in pregnancy. The drug was first introduced as Contergan in Germany, and was also marketed to treat anxiety, insomnia, gastritis and tension. The pre-marketing research by the manufacturer reported that the drug was perfectly safe and appropriate for a wide variety and large number of patients. Dr. Kelsey was suspicious when reviewing the drug safety data, though, and simply asked the U.S. manufacturer, the William S. Merrell Company, for more information. Merrell responded, but Dr. Kelsey stated that their data did not answer her concerns, and the company called her a petty bureaucrat and asked for her resignation. Dr. Kelsey persisted, and by 1961, many thousands of babies around the world were born with severe birth defects, thousands with flipperlike malformations of the arms that became associated with thalidomide. Dr. Kelsey saved many thousands of newborn babies and other patients from harm. She died in 2015, a hero.

Today, the ability of the US. FDA to actually protect the public from iatrogenic harm is much less than the public assumes, and is being further threatened by the pharmaceutical industry in ways that the public is ignoring. In 2015, a federal judge in New York ruled that the FDA could not prohibit promotion of a drug for unapproved uses. While this ruling was limited to the district in New York, and will be appealed by the FDA, this ruling for Amarin, and the drug Vascepa, which treats high triglyceride levels in the blood, but is approved only for more severe cases due to adverse effects, has been a desire of the pharmaceutical companies since the stronger enforcement of marketing and promotion laws in response to the thalidomide scandal, and especially with the now many tens of billions of dollars paid in settlements for more and more elaborate violation of promotion and advertising laws for "off-label" uses of prescription drugs. The mere use of the term "off-label", instead of potentially harmful or risky, creates an environment where this promotion is not taken seriously. The federal judge ruled that denial of promotion for a pharmaceutical that the company provided proof of effectiveness for these "off-label" uses was a violation of free speech! Such judicial philosophy is spreading to the pharmaceutical arena, preventing effective protection for the public and patient population. Free speech was used as a reason to deny workers their individual rights to coverage of contraception and abortion by an employer sponsored health insurance plan, denying individual freedom, and has been cited to deny serving an individual who is gay, lesbian, bisexual or transgender by any company or government agency that holds this to be against their religion. Now free speech is cited to allow any pharmaceutical company to advertise and promote drugs that the FDA medical authority has not approved. Prior to this, pharmaceutical manufacturers have freely omitted factual data, lied about their studies, heavily promoted drugs for off-label uses by using educational meetings and luncheons, as well as just giving thousands of dollars of the drug to Medical Doctors, and paid many thousands of public institution researchers to alter their research findings, and just passed on the enormous and mounting settlements for these infractions to the consumer, in the forms of higher drug costs, which ultimately create higher insurance costs, and higher government spending for the taxpayer.

The drug in question in this landmark case, Vascepa, is a synthesized omega-3 essential fatty acid, called ethyl eicosapentaenoic acid (E-EPA). The uses for this synthesized version of an omega-3 essential fatty acid found in krill oil supplement, and other natural sources, include psychosis, bipolar depression, borderline personality disorder, psychological stress, and mild elevations of triglycerides in Metabolic Syndrome. The drug could also be used to treat hepatitis C, ulcerative colitis, nonalcoholic fatty liver disease, and postmenopausal symptoms. The reasons for prescription of a synthetic EPA omega-3 rather than just the natural supplements and dietary changes is obviously to use a patented supplement to insure large profits, not because we need a synthesized form. So far, the company drug trials have shown safety, but it may cause increased bleeding time, inhibition of platelet aggregation, thrombus formation, weight changes and changes in lipid metabolism, as well as gastrointestinal complaints, such as stomach upset and diarrhea, and negative effects on the immune system. Of course, natural EPA, found in krill oil supplement, has none of these potential adverse effects, and is much less expensive. The total safety information available is from the 8 human clinical trials of the manufacturer, which lasted from one month to 2 years. While this particular drug appears to be completely safe, being just a synthesized version of a natural omega-3 essential fatty acid, the FDA is cautious in approval, for a variety of possible reasons. The point of this development is not the concern about this particular drug, though, but the achieving of the denial of the weak enforcement ability of the FDA for all other drugs. The creation of this drug appears to be intended as a complex tactic to undermine public safety protection by reversing the longstanding ability of the FDA to stop advertising and promotion of pharmaceutical drugs that are not proven to be safe, or where the benefits do not outweigh the health risks.

In 2015, even the American Medical Association (AMA) has called for an end to, or at least a great restriction on advertising and promotion for any pharmaceutical drug, because the evidence is overwhelming even to the industry that this is now causing much harm to public, as well as an untenable rise in the overall cost of healthcare. We cannot ignore the mounting harm from over-prescribing of drugs and polypharmacy any longer, and we cannot just assume that our prescribing Medical Doctors will do what is in our best interest. Many studies have now definitively proven that industry incentives, even just expensive lunches and dinners, have a profound effect on prescribing habits, and an array of issues create a complex system of justification for excessive drug prescription, including manipulated guidelines, manipulated studies, the promotion of the idea that there is no real therapeutic alternative in the form of Complementary and Integrative Medicine, patient demand from massive advertising that is misleading, and concerns about profit and income.

In 2016, rising concern for the heavily promoted but unproven field of stem cell therapy, and numerous reports of alarming adverse outcomes for use of stem cells, which can easily mutate and lead to new types of cancer, led the U.S. FDA to announce that they would start regulating this field of therapy as biologic drugs. Since 2004, the only regulations applicable largely concerned safe manufacturing methods, as is seen with medical devices, but in 2012 the FDA issued a warning that many of the applications of stem cell therapy altered the stem cells and turned them into a drug, not just a natural stem cell of the donor to be used on the donor. This warning led to a large number of clinics moving out of the country, and patients paying large amounts of money for unproven therapies that promised miraculous results but have produced great variance in outcomes, and in a growing number of cases, eventual harm. In an article in STAT, Dr. Paul Knoepfler, a researcher in stem cell technology at the University of California at Davis, stated: "It's a huge, unapproved human experiment." Control of media reporting by the health industry is creating an enormous threat of iatrogenic harm. A June 23, 2016 article in the New York Times, entitled A Cautionary Tale of Stem Cell Therapy Abroad, follows just one case of a patient, Jim Gass, who had now sufficiently recovered from a stroke and believed that there was no chance of harm from stem cell therapy, traveling to Mexico to obtain this treatment at great cost, only to discover that within a year or two, after seeing temporary benefits, these stem cells had created a tumor that filled the entire lower spinal column, and that could not be stopped in cancerous growth by the usual radiation and chemotherapy used in normal bone cancer. This man is now paralyzed with a very poor outcome. While the apparent focus of the article is on going out of the country to receive stem cell therapy, such treatment is still not overseen and regulated within the United States, as thousands of clinics backed by huge speculative investment have opened. Today, we see unproven stem cell therapy as injections, lotions, and tissue grafts, applied to a wide variety of health problems, and like the drug Thalidomide in the 1960s, widespread assurances that all of these are completely safe. Most of the stem cell therapies in initial application are minimally altered human mesenchymal stem cells, but as the field grows, we see many stem cell therapies that are altering the normal stem cells to a great degree and deriving them from tissue sources that are not well studied. Common side effects in the short term include infection, bleding, anemia, cardiovascular occlusive problems, GI symptoms, skin and hair problems, inflammation of glands, kidney and lung problems, heart disease, thyroid pathology, CNS problems, and infertility, as well as cancers. The long-term adverse effects will not be known for another decade. While the field of stem cell therapy presents enormous promise for many difficult health problems, a system that does little to protect the patients from iatrogenic harm is unconscionable.

Evaluating the Lack of Iatrogenic Harm from Acupuncture and Traditional Chinese Medicine - Decades of Misinformation Now Dispelled

While there are numerous anecdotal articles in the press talking about the potential for iatrogenic (associated with normal therapy) injury from professional acupuncture and herbal medicine over the last 4 decades in the United States, the facts reveal that the average yearly malpractice and office slip and fall liability for the Licensed Acupuncturist and herbalist is under one thousand dollars per year. Contrasted with the high costs of malpractice insurance for medical doctors, this alone reveals the level of safety and lack of actual iatrogenic harm from the profession. These apparent numerous articles and reports of iatrogenic pneumothorax and infection appear to be nothing more than a scare tactic and hoax. There is no actual United States Centers for Disease Control and Prevention study of the subject, since it doesn't happen. When studying all poison control centers and data collection of adverse effects from professional herbal medicine, here too, there is almost no reporting of actual injury from professional use of herbal medicine, only a plethora of accusations. Of course, individuals are poisoned by uneducated or purposeful use of herbal and food chemicals, but not as the result of professional herbalism and naturopathic medicine.

In 2010, the World Health Organization (WHO) conducted a broad multi-center study of the incidence of acupuncture-related adverse effects in China, headed by experts from the Tianjin University of Traditional Chinese Medicine, and from the University of Exeter, in Exeter, United Kingdom (England). These experts searched a number of standard medical databases in China in 2009, and found that from about 2000 total articles, that only 115 articles met their scientific criteria, and 98 of these 115 were just case reports, while 17 were case series, and only 20 percent of the authors practiced acupuncture. This means that in the whole of China, where acupuncture is widely performed on a population of one and half billion people, that over the last 9 years preceding 2009, that only 115 articles of actual harm from iatrogenic acupuncture treatment were alleged, all of them only case studies, and 80 percent of these were reports of clinical cases by medical doctors not practicing acupuncture, but alleging harm from the medical specialty that they themselves did not study. Further study revealed that only 11 cases involved allegations of infection, that 68 percent of the reported cases were from acupuncturists practicing in rural clinics and hospitals, where there is a great disparity in education and skill from those practicing in cities and receiving University or College Medical School training and education. Most of the traumatic iatrogenic harm involved pneumothorax, and was reported by the medical doctor treating the pneumothorax, not the doctor performing the acupuncture. Now, since spontaneous pneumothorax occurs in roughly 7-9 percent of the population, it is difficult to say that these cases weren't caused by spontaneous pneumothorax. The WHO noted that there were 2688 hospitals in China that provided care by doctors with TCM (Traditional Chinese Medicine) training, with perhaps 100 million acupuncture treatments per year in China. Obviously, the anecdotal and unproven reports of 115 actual cases over the years of iatrogenic acupuncture harm, when perhaps 100 million procedures per year are being performed, means that the actual incidence of such harm is so very minimal as to be of almost no concern, and that in reality, there is a possibility that the actual number of real cases of harm is just a fraction of 115! We should repeat the facts of this study: perhaps a fraction of 115 clinical cases of harm from the practice of acupuncture in over 900 million treatments!

Despite such studies, in China, Japan, Korea, the European Union, and Canada, all showing that acupuncture and the professional practice of Traditional Chinese Medicine has produced almost no harm at all, while standard medical care is producing an extremely alarming incidence of harm, the general population is still afraid of acupuncture. This is due to warnings and discouragement provided by standard medicine for decades, with obviously no basis in fact. It is also obvious that this medical specialty should be incorporated into, or integrated with, standard medicine to decrease iatrogenic harm.

Lessons from the study of hospital safety in 1850 by Florence Nightingale

While the image and caricature of Florence Nightingale that was repeated historically gave the impression that this educated and highly respected scientist was merely a simple nurse who demanded that the sheets be washed and the doctors wash their hands, the truth is that she was a renowned scientist who pioneered hospital design, evidence-based medicine, and guidelines for hospital safety that are still applicable today. Florence Nightingale carefully studied hospital safety and infection, controlled patient care in the institutions she served, was asked by the British Secretary of War to organize the corps of nurses in the military, consulted with the U.S. government during the Civil War to establish proper field hospitals, funded renowned hospitals on her own in London, and was granted the British Merit of Honor, as well as large monetary grants, most of which she accomplished from her bed, being stricken with Crimean Fever at age 35 and handicapped by the disease the rest of her long life. Her accomplishments in the field of medical safety and statistics made her an important pioneer in medicine, yet the fact that she was a woman led to a depiction as a simple nurse, the "Lady with the Lamp".

In her 1859 study of hospital safety, Notes on Hospitals, she outlined succinctly and simply the main mistakes seen statistically that led to hospital deaths and injuries, or iatrogenic harm. Some of these are still applicable today, and the lessons were not apparently learned. For instance, she stated that superficially, we look at hospital design as merely the disease and the treatment, ignoring the healthy function, vitality and spirit of the patient, which is all important to recovery. She pointed out that the most harm came from the largest hospitals, for a variety of reasons, and recommended that all hospitals be limited in size. She pointed out that most infections were viral, and that the air carried the pathogenic viruses, not just direct contact, so that it was very important to have freely circulating air, and air from the outside, to decrease the concentration of the virus. She advocated what are still called Nightingale wards, because confining the patients to enclosed rooms increases the risk that concentrations of pathogenic viruses would occur, as well as the fact that social contact for the patients reduced the time of recovery. The effect of direct sunlight on the patient population was also stressed, again statistically found to speed and increase recovery.

Deficient hospital kitchens were also found to be statistically related to poor outcomes in the research conducted by Florence Nightingale, and providing fresh healthy food that is individualized for the patient and their recovery was very important to her outcome statistics. While we did establish an elaborate nutritional department in hospitals and assign a nutritionist to each patient, everyone is well aware of the unhealthy quality of hospital food. Ms. Nightingale also stressed that hospitals should not be allowed to be built in busy urban environments, where smog and noise contribute to ill health. She carefully studied the physics of ventilation, and found that sufficient ventilation was hard to achieve, requiring that ceilings be between 12 and 15 feet high, and windows be large and allow a sufficient flow of air up to the ceiling. Today, windows usually do not open, and while there are air filters, the flow of air in hospitals is grossly insufficient to dilute the air. She also emphasized that hierarchy between doctors and nurses be reduced, with all medical personell acting as a team, that sufficient staffing of nurses be required, and that hospital design encourage increased efficiency in supervision of the patients. While many of the particulars of hospital design from this time may not be entirely applicable to modern requirements and technology, the basic ideas of natural holistic environmental health are still very applicable, yet largely ignored. If we would finally pay attention to the sound scientific research and recommendations of Florence Nightingale, we would all by safer, and our hospital care system would be much improved.

Additional Information / Information Resources and Links to Scientific Studies

  1. The first in a series of investigative articles on iatrogenic injury and death in U.S. hospitals from what is termed medical error, most of which is preventable if the philosophy of medicine is changed - these articles, by the award-winning and Pulitzer Prize nominated Marshall Allen, was published in Pro-Publica, Journalism in the Public Interest: http://www.propublica.org/article/how-many-die-from-medical-mistakes-in-us-hospitals
  2. A 2012 study by the Swiss Patient Safety Foundation, found in an anonymous survey of physicians and nurses in primary care offices that 30 percent of physicians, and about 17 percent of nurses reported that at least one significant medical error occurred daily or weekly in their offices, and the reasons for errors resulting in severe injury or death included diagnostic errors, medication errors, failure to monitor patients after procedures, and test or intervention errors in that order of significance. Staff working in larger medical centers reported higher frequencies of such medical errors: http://www.ncbi.nlm.nih.gov/pubmed/23009331
  3. A comprehensive study of Iatrogenic harm in standard hospital care was performed in 2003, published in the esteemed Annals of Internal Medicine, and compiled by experts from the University of Ottawa, Ontario, Canada, and Brigham and Women's Hospital, associated with Harvard Medical School in Boston, Massachusetts, U.S.A. In this conservative study we see that nearly 20 percent of patients experienced significant and often preventable adverse health events after being discharged from hospital care, often due to a system with poor communication and coordination of care. Many of these preventable adverse health events could be ameliorated by integration with Complementary Medicine during hospital discharges as well, providing an affordable protocol to both monitor patients' health and provide further conservative care and improve quality of life: http://hospitalmedicine.ucsf.edu/improve/literature/discharge_committee_literature/reengineering_systems/the_incidence_and_severity_of_adverse_events_affecting_patients_after_discharge_forster_ann_intern_med.pdf
  4. A series of articles on the state of hospital safety in the United States by Forbes, a conservative business magazine in the United States, shows that the situation has gotten increasingly worse since the first study of this problem in 1999, and persistent efforts to hide these facts by the health industry reinforced by enormous lobbying efforts have succeeded. Such reporting by the most conservative of business media clearly outlines the extent of the problem: http://www.forbes.com/sites/leahbinder/2013/07/15/bone-chilling-mistakes-hospitals-make-and-why-they-dont-want-you-to-know/
  5. A 2015 report to the U.S. Congress by the FDA showed that a study of 20 types of laboratory tests found that a large number of patients are harmed each year from standard tests that are prone to false-positives (patients do not have a positive finding but are told that they do and are misdiagnosed), tests proven inadequate to diagnose but still widely used, tests that produce high rates of false negatives (fail to positively detect the disease marker), tests still used despite the fact that the findings have been proven to have no clear relevance to the disease, genetic tests that have been found to have no relevance to the disease, toxicity tests that have been proven inaccurate, and other problems. Some of the tests are tied to prescription of drugs, and even to drug trials, and concern cancer diagnosis, HPV, autism, chronic fatigue syndrome, and Lyme's disease: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf
  6. Deadly hospital-related bacterial infections, such as multi-drug-resistant, or pan-resistant Acinetobacter, which experts at Nottingham University Hospitals, in the United Kingdom, state had emerged in the 1970s with overuse of broad-spectrum antibiotics in hospitals, have re-emerged globally again as antibiotic resistance becomes even more of an issue. Obviously, such bacteria were not carried directly from one intensive care patient to another, or on their sheets, globally. The failure to understand and accept the ubiguitous nature of microbes, and the holistic approach to countering such infection, persists despite the obvious failures of our attempts to control healthcare-related infections: http://www.ncbi.nlm.nih.gov/pubmed/19700220
  7. A number of studies have shown that probiotic therapy may be helpful to prevent Clostridium difficile-related diarrhea in the hospital setting, and transfusion of health matched biota is proven to cure difficult and threatening cases. A study in 2013, at Gifu Municipal Hospital, Gifu, Japan, randomly studied 2716 patients admitted to the hospital and concluded that a course of simple probiotics prior to admission did not have a significant effect to reduce risk, but that a number of factors increased risk, such as an 8-day course of antibiotics, standard medications to treat stomach acid, and the use of intravenous nutrition: http://www.ncbi.nlm.nih.gov/pubmed/24020129
  8. A 2010 report from the Harvard Health Publications of Harvard Medical School outlines the growing problem of antibiotic-associated diarrhea and the alarming number of cases of serious harm and death attributed to Clostridium difficile infections in the hospital, not because Clostridium difficile exists only in hospitals, since it is a common strain of commensal bacteria, ubiquitous in the environment and in our intestines, but because antibiotic-resistant strains are now very common and pathogenic, and because our hospital systems do not do enough to increase the patient health and resistance to these infections: http://www.health.harvard.edu/staying-healthy/clostridium-difficile-an-intestinal-infection-on-the-rise
  9. A study and review of specific probiotic therapies to treat or prevent nosocomial infections (hospital-acquired) with Clostridium difficile, in 2013, at Paracelsus Medical University, Strubergasse, Salzburg, Austria, found that treatment with a specific multistrain probiotic cocktail, as well as fecal biotic transplants, produced a 100 percent success in resolution of diarrhea and infection, as well as prevention of recurrence: http://www.ncbi.nlm.nih.gov/pubmed/23434948
  10. A study of estimated healthcare-acquired infections in the United States was finally performed for the U.S. CDC in 1999, with an estimate of 99,000 deaths attributed. The authors cite the obvious limitations on accuracy in the report, depending on data from prior years, before the advent of widespread antibiotic-resistant bacterial strains in hospitals from overuse of antibiotics, and the system of reporting, where the cause of death is usually a choice between various potential causes, and the person reporting the cause of death perhaps influenced by various factors in a voluntary system. Hospitals would suffer repercussions if the number of healthcare-related infections were too high in the reporting. The total number of estimated healthcare-acquired infections in 2002 was 1.7 million, and the great majority of these were attributed to bacteria that arrived within the patient, not acquired from the environment. A stubborn refusal to consider measures to increase the innate immune protections of the patient to reduce this extremely high number continues. Healthcare science appears stuck in the 19th century in this regard, and even still ignores the advice of the most renowned physician of that century regarding hospital care, Florence Nightingale, who single-handedly revolutionized modern medical hospital safety by stressing the holistic health of the patient: http://www.cdc.gov/hai/pdfs/hai/infections_deaths.pdf
  11. A 2012 meta-review of the efficacy of pneumonia immunization and the PPSV pneumococcal pneumonia vaccine, by experts at The Veterans Affairs Western New York Healthcare System and State University of New York at Buffalo School of Medicine, found that the vaccine efficacy as reported by past clinical trials are questionable due to conflicting RCT study results, the lack of trials the were inclusive of the target population of those age 65 and older, and the hypo-responsiveness of the vaccine over time and with a second vaccination. These experts also noted that all of the efficacy of the viral vaccines are derived from observational data, or anecdotal, and even this data is extremely variable and dependent on the virulence of the viral strains each year, the problems of matching the vaccine to the 3 most viral strains, and by varying cohorts: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3496196/
  12. A 2011 study and review of all scientific study regarding hospital-acquired pneumonia association with overprescription of gastric acid inhibiting drugs, performed by experts at the University of Michigan School of Medicine and Hospitals, noted that there is a high association between these drugs, such as proton-pump inhibitors (Nexium, Protonix, Prevacid, Omeprazole) and hospital-acquired pneumonia. The reasons for this is the reduction of the natural gut immune protections engendered by use of these drugs. The use of acid-reducing drugs also doubled the risk of acquiring Clostridium difficile diarrhea in the hospital. Restoring gastric function and improving gastrointestinal health and immune function with Complementary Medicine would actually lower the incidence of these infections, theoretically: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124633/
  13. A 2009 multicenter study based with the University of Toronto, Ontario, Canada, showed that in a 6-year population-based study of 13,636 patients taking a gastric acid inhibiting proton pump inhibitor other than pantoprazole after experiencing a heart attack (myocardial infarction), that this increased the risk of a second heart attack in the near term by 40 percent, due to adverse drug interaction between the gastric acid inhibiting drug and the blood thinner Plavix (clopidogrel), because of a competitive inhibition of P450 2C19 cytochrome controlling the rate of breakdown of the drugs. Such negative drug-drug interactions are largely ignored in standard medicine, as more and more prescription medications are prescribed at the same time to patients. On the other hand, it is common to find warnings about drug and herbal competition for these cytochromes, although this data is acnecdotal, with no actual proof of harm, concerns just a few herbal extracts, such as St. Johns Wort (hypericum), and these herbal extracts are normally prescribed short-term in such small doses that they could not possibly have an appreciable effect. Such studies as this shows that patient iatrogenic harm is routinely overlooked and ignored, while the beneficial effects of herbal medicines are discouraged, despite the fact that use of restorative therapy with herbal medicine could reduce the dependency on multi-drug regimens that incur much risk for patients: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2659819/
  14. The data supporting the alarm of adverse drug-drug interactions in hospital care is nothing new. In this 1998 meta-review of past studies of this problem, published in the esteemed Journal of the American Medical Association (JAMA), researchers reviewed the published studies between 1966 and 1996, and concluded: "The incidence of serious and fatal ADRs (adverse drug reactions) in U.S. hospitals was found to be extremely high". Such studies as this still did not highlight the actual threat risks, though, choosing to sidestep the actual source of the adverse drug reactions, but using the WHO definition of any unintentional and undesired effect from normal dosage prescription, and excluding medical error, therapeutic failure, overdose, or drug abuse. The subject of negative drug-drug interactions is not even addressed in the study summary, but is evidently of chief concern: https://www.vitapurity.com/reference/jlt1125-1.html
  15. As far back as 1994, studies of hospital-acquired infections such as this one, at the University of Barcelona, Spain, found that prior use of corticosteroid medication and antibiotics was highly associated with risk of pneumonia acquired in hospitals, as was prior incidence of COPD, and that the risk of acquiring and antibiotic-resistant pneumonia was also increased significantly. Such studies did not result in the decrease in antibiotic and corticosteroid use, which instead increased in prescription dramatically, and did not result in a change of treatment protocols for COPD, for which standard medicine has little to offer except control of symptoms with combo corticosteroid and albuterol inhalers: http://www.atsjournals.org/doi/abs/10.1164/ajrccm.150.6.7952612#.UpTEGI3t4ok
  16. A 2012 study at the University of Barcelona, Spain, found that the use of corticosteroid medication for critically-ill patients, now common practice in hospitals, is strongly associated with increased risk of death in patients in intensive care units with healthcare-associated infections, yet before this there were almost no studies addressing this issue, and no statistical disincentive to use corticosteroids more judiciously in the hospital. After this study was released, several other small studies showed no statistically significant increase in mortality, but did show that significantly longer hospital stays were associated. The fact that patients not receiving corticosteroid medication had about the same rate of mortality in these other studies did not result in a recommendation that the corticosteroids may not be necessary in a large number of these cases of hospital-acquired infection, but rather the opposite occurred, a recommendation to continue the widespread prescription of corticosteroids, which come with a long list of warnings and adverse health effects. This attitude in hospital care was indicative of the systemic problem: http://www.ncbi.nlm.nih.gov/pubmed/22732293
  17. A 2010 study at the Medical Centre Alkmaar, in The Netherlands, showed in a randomized human clinical trial that the corticosteroid Prednisolone did not improve outcomes in hospitalized patients with moderate to severe pneumonia, and that failure to control the pneumonia after 3 days of treatment was 3 times higher in patients receiving the corticosteroid therapy. The recommendation was that corticosteroids should not be routinely prescribed in hospitalized patients with pneumonia: http://www.ncbi.nlm.nih.gov/pubmed/20133929
  18. A 2011 meta-review of published studies of high quality concerning adverse effects of drug-drug interactions in the care of the elderly, but the University of Arizona College of Pharmcy, in Tucson, Arizona, U.S.A. found that there is significant harm associated with drug interactions in elderly patients that is largely ignored. Common adverse effects between hypertension medications, such as ACE inhibitors and potassium sparing diuretics, and ACE receptor blockers, perhaps prescribed for the majority of elderly patients in nursing homes and hospital care, between sulfa and other antibiotics and various drugs, including andt-depressants, anti-seizure medications and benzodiazepines, and between blood thinners such as warfarin and NSAIDS were highlighted. Adverse effects between tamoxifen for reduction of breast cancer recurrence and paroxetine, an SSRI antidepressant were also highlighted, increasing the risk of cancer recurrence: http://www.ncbi.nlm.nih.gov/pubmed/22078863
  19. One proposal to reduce the infant mortality rate in the United States is the adoption of true integrated care with midwives, which has been adopted in many countries and proven to be effective. While we still treat midwives in the United States as radical and dangerous alternative healthcare providers, ostracizing them, and often denying them the integrative access that they need to handle all emergencies effectively, Midwifery in the European Union has been accepted and successful for decades: http://www.nightingaledeclaration.net/global-news/646-better-birth-outcomes
  20. The American Holistic Nurses Association was founded in 1981, and has since been accepted and accredited by the American Nurses Association as a specialty, but is still not supported by the medical industry, utilized, or understood by the public: http://www.ahna.org/About-Us/Past-Present-Future
  21. A broad 2010 multicenter study of actual iatrogenic harm from the practice of acupuncture in China by the World Health Organization reveals that the incidence is almost entirely anecdotal, not proven, and that will an estimated 100 million acupuncture treatments per year performed in Chinese hospitals, that only 115 case studies alleging harm were found in the Chinese medical databases in the years preceding 2010. Since the practice of TCM (Traditional Chinese Medicine) is derided by the standard medical profession as much in China as in the U.S. there is no possibility that the profession would be protected in standard medical journals, quite the opposite. This is proof that that alleged potential of harm from acupuncture is so minimal as to be not worthy of actual consideration, and that this practice is the safest manual medical treatment in world history: http://www.who.int/bulletin/volumes/88/12/10-076737/en/
  22. The regulation in the United States of stem cell therapies, cellular and gene therapies is woefully inadequate, with applications of regulation created in 2004 that only apply to best manufacturing practices and offer guidelines that are largely voluntary to apply the best industry standards. The health industry states that these new therapeutic tools are FDA regulated, but appears to be misleading the public as to the extent of safety regulation. To see the 2016 FDA guidelines, which are very obscure, just click here: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/
  23. In response to the woefully inadequate public protection in the field of stem cell therapy, the U.S. FDA issued a warning letter in 2016 that due to the fast rise in this field before safety has been established, that the FDA now would need to start regulating stem cells as biologic drugs: https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/