by Rose Rohloff
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
The 1974 Research Act was created in entirety from the Belmont report, and put into place to prevent the Government, it agencies or representatives, military and private companies, from violating an individual's freedom: by forcing, tricking or coercing persons for research, testing and administration of unknown injections/materials, and experimental procedures. This law was enacted after a century long track record of precedence including, and not limited to, the following:
Demonstrated lack of Respect for Persons and their protections in violation of 1974 law.
1- Autonomous agents, individuals capable of deliberation about personal goals and of acting under the direction of such deliberation. The Government and companies have to give weight to autonomous persons' considered opinions and choices, and cannot obstruct their actions and judgments, nor deny individual freedom to act on considered judgments, and cannot withhold information necessary to make a considered judgment. Necessary information includes - but not limited to - all medical opinions by established, industry experts, health status, the necessary assessments, labs, with close monitoring of physical lab and test follow ups of each and every autonomous persons as part of clinical research and testing, along with full documentation of testing, efficacy, use of chimera for research and testing, any and all conceivable side effects, and interactions of conditions.
2- persons with diminished autonomy are entitled to added protections.
Violators to the law have been marketing to the most vulnerable, including the immature and the incapacitated who were in need of extra, added protections, even to the point of excluding them from any injections or procedures which may harm them; violating added safety precautions for children, elderly, or those with diminished capacity.
Informed consent - must include full disclosure of ALL contents to be injected, any and ALL possible side effects (which can be several pages long), how those persons are individually to be closely monitored, safety guidelines, and above all the right to say no before or at any time, and full reporting of all individuals regarding their safety monitoring/labs/assessments, and any and all side effects. By promoting COVID shots all still under clinical trial/research, and coercing with careers/jobs, inability to travel, etc. in order to take the shots, this law is being violated through: lack of informed consent, lack of protections of autonomous persons, and/or illegally acting as IRSB board members marketing to those not autonomous and capable of self-determination, with higher standards of protection to be invoked, and assuming the role for their safety.
The maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others.
An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.
Undue influence also includes offers of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable as in the case of targeting children, persons with limited capacity, and elderly with elements of mental defect, or instilling fear.
Short term morbidity and mortality cases from the shots are well reported and known, such as death, myocarditis along with spontaneous cardiac arrest with no warning, debilitating neurological conditions, etc. And, there is no means yet to determine mid and long term effects because Phase I trials have not been competed, let alone Phase II and III - which is vital information in order to determine informed consent.
Injustice has been performed with companies and government representatives, by involving vulnerable subjects, including the young, those unable to fully comprehend with all necessary information, and scaring parents with compromised capacity for free consent. In addition to lack of individual, tightly scheduled, continual monitoring and follow ups, autopsies of all persons involved in this trial participation should be conducted for reporting by the pharmaceuticals companies for any and all persons who received the shots, as well as labs determining efficacy and detriments (as examples, antigen creation, D-dimer, Pulse Cardiac and Troponin Tests) for all those who were coerced or unduly influenced to participate in research.
This law was created to protect people from government abuse through experimentation. The government cannot arbitrarily dismiss components, create resolutions or stipulations to supersede the law, as to invalidate its protection of individuals from them, including, but not limited to Health and Human Services (HHS) Center for Disease Control (CDC), Food and Drug Administration (FDA), National Institute for Health (NIH), etc. and pharmaceutical companies, etc.
Persons have been illegally acting as members of, or bypassing, IRSB safety review and monitoring of each and every person receiving injections, with open undue influence and coercion, to participate in Covid injections. Coercion has been especially directed to the diminished autonomous, children and elderly, through TV ads, library recordings, verbal encouragement, schools or other public venues acting as government agents, and/or clinical researcher recruiting participants, and/or illegally as untrained IRSB member who is not following up to ensure safety of the people they recruited, coerced or used undue influence.
Overall lack of informed consent has become too often common practice across the healthcare industry, including people being given consent forms hours or minutes prior to surgery; no alternative treatments or lifestyle-nutrition changes prior to medications begin prescribed, and undue influence to intubate or perform surgery on patients in lieu of alternative treatments.
by Rose Rohloff
The baby boomer generation is now the growing population of elderly with more care needs in home health. As the current generation is being faced with the care responsibilities, many are still unaware concerning various facets of caring for others: advanced directives and living wills; stimulation and diets for mental sharpness, questions to ask and quality of care considerations with becoming power of attorneys - the core of healthcare awareness. One area is focused heavily within hospitals and other care delivery environments, but yet over looked in private homes – surface areas and cleanliness.
A popular trend in houses is the use of marble and granite as counter tops. A leading surface expert, Linda Lybert President of Healthcare Surface Consulting stated, “Granite and Marble are like large sponges you cannot wring out.” The photo displayed shows the build up of E. coli bacteria in the pores of stone. According to Ms. Lybert, even when sealed, the porousness is reduced, but not eliminated. And, bleach is not able to eliminate once they reside in the crevices.
All surfaces in the home, counter tops, floors including laminates, tile and grout need diligent daily cleaning and disinfection. However, Ms. Lybert brings awareness that regarding "stone surfaces, including granite/marble, there is no effective means to disinfect these surfaces." Consider, "granite is an underground aquifer for our water filtering out all kinds of things. Given the right kind of environment, heat and moisture, bacteria will grow."
As the elderly begin to lose their mobility and agility, it is important to maintain clean surfaces in bathrooms and bedrooms, along with the most important surface being the skin. Diligent hand washing and bathing is important throughout the day to avoid cross contamination from the loved one you are caring for, as well as to them. The other surface area to be conscientious of is bedding. When excrement accidents occur, it is important to wash bedding with very hot water to not only clean them, but also kill the microbes.
Clostridium difficile (commonly known as C-diff) "is in the community and found in outpatient settings. There are significant risk factors in patients who are immunosuppressant, individuals who have been on antibiotic therapy, and the elderly population." C-diff is a secondary, very dangerous and potentially deadly infection after antibiotic use. [read article] It is important to those in the community to have appropriate antibiotic prescriptions and use, especially avoiding unnecessary broad spectrum antibiotic use which targets the "good" bacteria you need internally (and not on external surfaces) to kill off C-diff.
Population Health: has the focus on big data, populations & large systems caused the loss of individuals?
by Rose Rohloff
A Memorial Day quote yesterday regarding veterans also exemplifies much of what has happened in healthcare over the last 10 years, regarding the focus on Population Health, meaningful use reporting, value based analysis, big data analytics-claims data, and mergers of health systems with large EMRs, with focus on reporting.
“We are arguing over a statistical analysis. This is the challenge that we face in society today ,,, we are quantifying numbers because it’s easy to look at a number, and it’s not easy to look at the value of a human life. I would say to you today that (losing) one a day, one a year is too many.”
Kyle Reyes, CEO, The Silent Partner Marketing
When the primary focus is on data (the multiple of numbers/records-statistics), singular records and numbers or outliers are not worth the time and effort of analysts and executives. And yet, they should be as each record is a real patient, a friend, a loved one.
The solution is bringing analysis down to the most base level of management with front line analysis, to coincide with first-hand observation, the voice of the patient & their caregivers/champions, and reducing the ever growing administrative overhead. Bigger is not better for addressing health and care of populations, when the focus is shifted upward with large systems where individuals are lost: Especially when the individual issues are indicative of the core problems that need to be addressed for quality care delivery.
The need for P&P Reviews
Numerous reports of discarded, used syringes in the streets of major cities, such as San Francisco, also necessitate being aware of 'sharp safety' in the community. Whether a street, park or playground, it is good to have knowledge of what to do, and teach your children, regarding needle-syringe safety. The following are just a couple example guidelines:
by Rose Rohloff
Naloxone is an emergency medication; it is temporary and doesn't stop or eliminate opioid abuse, addiction.
This week, reports were released in the media that US homes need Narcan to aid in opioid overdose epidemic, surgeon general advises
Dr. Delos Marshall "Toby" Cosgrove, the previous CEO of Cleveland Clinic, spoke to a room of healthcare leaders from across the country about the Opioid Crisis in April 2017. The discussion centered around the abuse of taking prescribed medications - legally and illegally - with the current trend of NARC Parties. He explained that NARC Parties entail the supply of Naloxone (the common brand name is Narcan, used by hospital-emergency personnel as the medication to temporarily counteract a narcotic or heroine overdose.) He continued that having Naloxone allowed people to overdose, the person(s) were then given Narcan in order to continue partying.
The general public needs to be aware: Naloxone has been reported to foster increased abuse of drugs by allowing revival of overdosing for continuing to take more drugs. Naloxone is the generic of Narcan. Just as EpiPen is only the delivery system and not the generic drug Epinephrine, It is important to know the difference between the brand name versus the generic drug name.
The danger of advising the untrained public to distribute emergency medicine
"A serious problem is many doctors and many more nurses are unaware of the different mode of metabolism of Fentanyl and Methadone. With various dosages of Fentanyl and Heroin or combinations of other opioids, the efficacy of Naloxone or Naltrexone is compromised. The general public (let alone many new doctors and nurses) do not have a working understanding of the differences in these competitive antagonists." "There may not be any impact for at least 30 minutes with a basic spray." 45 year RN, BSN, NP, MSN, Committee Member Opioid Crisis, Board of Directors Health Facility
Many clinicians, let alone the general public, are not specifically trained in the proper dosage and treatment with Naloxone for the various forms and dosages of opioids and heroin.
FDA Advisory Committee on the Most Appropriate Dose or Doses of Naloxone to Reverse the Effects of Life-threatening Opioid Overdose ... Sept 2016
"The effectiveness of naloxone, and thus the exposure required, will depend on the opioid dose, the potency of the opioid in binding receptors, the lipophilicity of the opioid in crossing into the CNS system and the elimination half-life of the opioid, together with patient factors (7, 26). Appendix  and [2a] includes further information on naloxone pharmacology. The complex pharmacology of appropriate dosing is further compounded as often the fentanyl involved is illicitly manufactured without normal procedures or controls and may be introduced surreptitiously into heroin or prescription painkillers. Reports from the field confirm the need for additional naloxone doses to reverse opioid overdoses including those involving more potent fast onset synthetic opioids."
Narcan (Naloxone HCL) Use in Opiod Overdose: A Perspective
An important point for the general public who is not used to or trained in emergency medicine, this “rescue” drug is only the first step in the opioid crisis ... not the end all and be all of treatment. I would like to respond to this “advisory report” from the Surgeon General as a pharmacist, an Emeritus Professor, Pharmacy Practice from a College of Pharmacy, former President/Chair of the Michigan Pharmacist Association (MPA) and Fellow of this Association; and lastly as a chronic pain patient.
I have used opioids now for chronic pain management after a car accident almost twenty-years ago. I will admit, I was taken aback by my family physician about a month ago being given a prescription for Narcan (generic name Naloxone) as a “precautionary measure” for my chronic opioid use. The form I was prescribed is a nasal formulation vs. the oral/injection form. When I took it to a pharmacy to be filled, I had to undergo “special counseling” by a pharmacist (even with my credentials) which consisted of a video on proper use and a warning that after use, 911 had to be called and I was to be taken to the emergency room for follow-up. This is the proper follow-up when someone is prescribed any rescue medication for a drug reaction. The Naloxone is only to be given when a known opioid (i.e. codeine and it’s derivatives; Fentanyl, Meperidine, etc...) is given or taken in life-threatening incidences. I was instructed, "Were you aware that Naloxone has two elimination half-lives because this drug has an active metabolite; and, were you aware that Naloxone and Naltrexone are different agents, but are easily confused."
I believe giving someone this agent for overdose situations is giving a false sense of security that nothing else needs to be done. Nasal Naloxone is like putting a bandage on a cut artery. You may stop the blood flow at the moment, but the wound will continue to bleed if the wound isn’t sutured properly. Without appropriate emergency room follow up of an opioid overdose the person may die from that overdose.
Many opioids vary in dose, strength, predictability and most of all drug half-life. Knowing the half-life of drugs is essential to know how long the drug is going to last in your body. Drug half-life’s, drug absorption, distribution and elimination is well covered in Colleges of Pharmacy in courses such as pharmacology, pharmacokinetics and pharmacotherapeutics. Pharmacists do not know the pharmacokinetics on every drug substance out there by memory, and we are called the drug experts. Physicians do not have nearly as much education on medications as pharmacists, yet they are the first line of treating drug overdoses in emergency situations along with the nurses, Physician Assistants and Nurse Practitioners.
The general public is being provided a false sense of security by the media to carry this drug in their homes to address the opioid crisis. The public needs to be AWARE there is more to treating an opioid overdose than just squirting this agent up their nose.
Joan M. Rider-Becker, BS, PharmD, FMPA
Retired, Emeritus Professor, Pharmacy Practice Ferris State University College of Pharmacy
B.S. Pharmacy-Ferris State University College of Pharmacy-1987
Pharmacy Practice Residency-Bronson Hospital Kalamazoo, MI-1987-1988
Doctor of Pharmacy (PharmD), University of Michigan-College of Pharmacy Ann Arbor, MI 1990
What has caused the layering of medications
The country is currently facing increased antibiotic resistance, opioid crisis, etc. due to our culture being conditioned in the taking of medications versus alternative treatments, or prescriptions of medications without diagnosis. A mother of a small child was recently told by a doctor as part of her son's care, "It is very important for you to teach your child how to swallow pills. Start with candy sprinkles, then swallow mini M&Ms, and then have him swallow large M&Ms so he can take multiple pills at the same time." This instruction was given to the mother without a diagnosis for her son, no plan to achieve understanding of what was causing his pain to then create a plan of care - which may or may not have needed to include medication.
Consumer engagement is needed with all medications being prescribed to be fully empowered, to understand: 1) the need for prescriptions, why and when appropriate, 2) the side effects of medications to determine alternatives versus adding on more medications, and 3) to eliminate the misuse of medications without the continued layering of additional drugs. Antibiotics should only be used when the body, given time, cannot fight a severe bacterial infection. And, antibiotics should only be given out after a culture is performed to eliminate a virus as the cause, or to target the specific bacteria. Broad spectrum antibiotics should only be used with life threatening-septic issues while waiting for a culture, or there is not the ability to perform a culture.
by Rose Rohloff
Last week, Jeff Bezos, Warren Buffett and Jamie Dimon (I reference as the BBD solution) announced their focus for healthcare. Here are thoughts from an industry insight perspective to think about. The industry needs major shakeup for transformation to occur. BBD are technology giants focused on technology and employer offered care. This expansion will likely be predominantly that of Telemedicine, Amazon electronic medical record (EMR), and investment in technology companies. Our current system is the push for capitation (covered lives/socialized medicine, Medicaid expansion) with the focus of technology as the solution. BBD is moving this model under companies, and will impact costs. However, technology without personal and personnel intelligence with sound processes is the continued automation of bad practices and "garbage in - garbage out" data, with the potential for expanding the 'fast food healthcare' of symptom=prescription, unless we start addressing the true underlying issues impacting quality, the needed personal and personnel intelligence with mutual accountability on consumers & providers. We currently have the increasing issue of people causing accidents and walking into walls with the advancement of cell phone technology, with more and more technology trying to replace basic awareness and personal intelligence. We need to avoid the same mistake with healthcare delivery with more and more expensive technology driving up costs, without first addressing basic sense solutions.
February 14, 2018 Telemedicine is a tool that can be very effective depending upon how it is used. Top 5 Ways Telehealth Will Change Under the New Federal Funding Bill, "The new federal Bipartisan Budget Act of 2018, signed into law by the President on February 9, 2018."
Theranos - many lessons learned but the main important lesson has not been talked about
by Rose Rohloff
Learned lessons from the devaluation and closing of Theranos labs and blood testing centers include the lack of transparency, the need for thoroughly vetting new innovation, the requirement to understand the market, the need to support vision with qualified proof of concept, as well as deficient oversight and due diligence, to name a few. One lesson of success, however, has been overlooked – the model that was established. [read more]
The healthcare industry has used perioperative morbidity and mortality reviews (M&Ms) for blunt evaluations, to continuously improve the understanding of and performance in surgical intervention. Since the industry touts Population Health and Patient Engagement as top initiatives, health systems can use the successful process of M&Ms to perform Population Health and Patient Engagement reviews (P&Ps) of individual cases, for ensuring quality care processes. [read more]
"Those in healthcare are there for the patients, the patients are not there for them. If we stopped for a moment to view the actual words 'patient,' 'health' and 'care,' there is no 'I' in either 'health' or 'care,' only in the word 'patient.'" Those in the healthcare industry tout the idea of prioritizing patients by using phrases such as "patient-centric" and "patient engagement," and yet current data trends suggest the contrary is happening. Instead, motivation based on self-interest continues to permeate care delivery. Here are three trends in the healthcare industry that work against patient-centered care. [read more]
Domain experts sharing leading expertise for consumers.