Over the past 30 years Western Medicine has taken over the world’s stage for health care, becoming the standard by which we make decisions for treatment. Organizations like the World Health Organization and the Center for Disease Control have become the authority that provides the guidance that direct Government regulations, oversight, and reimbursement from healthcare providers. These Non-Government Organizations and Western Medicine in general have failed to provide solutions that revitalize human health and well being.
Sadly, it’s not because solutions don’t exist or haven’t been proven in the clinical evidence and research conducted using the traditional standards of Western Medicine. It would appear that the standards of care and even the goals of Western Medicine have nothing to do with the well being of the individual patient. Western Medicine treats disease rather than people, and furthermore it isn’t concerned with the unique circumstances of each person so much as the collective perception of what is for the “greater good”.
A glaring example is the recommendation and consequent approval of the medication Remedesivir for the treatment of COVID-19. The poster boy for Western Medicine and head of the NIH, Dr. Anthony Fauci claimed that the results from the initial study of Remdesivir were very encouraging and would change the standards for treating COVID. Upon further examination the study referenced by Fauci yielded a 50% death rate of those receiving Remdesivir and the drug was removed from the trial because of it’s horrible outcomes.
In this example, one of three conclusions can be drawn: Dr. Fauci doesn’t know how to review clinical information, which seems unlikely because he’s been a Clinical Researcher for over 30 years. Dr. Fauci is seeing something far beyond our comprehension to draw his conclusions and thus we have to assume that COVID poses a greater threat than a 50% chance of loss of life and that Fauci has superior skills as a Physician that are beyond our low level of perception. Or thirdly, and most likely, Dr. Fauci isn’t and was never looking to save the most lives, but rather to eliminate the highest number of lives for the “greater good”.
This development is common amongst Medical Professionals who often justify bad Medical practice by making decisions based on standards dictated by Health Care Coverage and Non-Government Organizations. The perception is that the poisoning and management of human health, life span, and disease is justifiable homicide necessary to prevent over population.
The core of this psychological operation lies in the initial myth of Carbon emissions being at the core of Global Warming and Climate Change in general. The Greater Good Theory is that it’s necessary to manage the alleged overpopulation to decrease Carbon Emissions. That being said, for people to emerge from this Military genocide it’s essential that we know our rights and understand the recommendations of the alleged experts before we make any decisions about medications we use for ourselves or our families.
In this section of the Health Center we will constantly be explaining and exposing the good and bad of the pharmaceutical culture of Western Medicine. We encourage enlightened Medical Professionals to share valuable clinical interpretations of common and unique research in an effort to create a more educated consumer.
BEFORE EXPLORING PRESCRIBING INFORMATION
The article and research below details the many factors that explain why bad decisions are made so often by Western Medical Doctors when it comes to the manner in which they prescribe drugs and biologics for their patients.
Physicians’ use of and preferences for FDA-approved prescribing information
Abstract
Background
The Prescribing Information (PI) is the US Food and Drug Administration (FDA)’s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] One challenge with this type of communication is balancing the need to be thorough with the need to be concise.
Objectives
This study aimed to explore physicians’ preferences for and understanding of specific content and formatting in the PI. This study also explored physicians’ use of and perceptions of the PI.
Methods
Seventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians’ interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI.
Results
The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., “with or without food”) in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list.
Conclusion
This qualitative research suggests physicians may prefer more clarity in some sections of the PI.
Introduction
The Prescribing Information (PI), a type of FDA-approved labeling, is the US Food and Drug Administration’s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] The PI must be informative and accurate and neither promotional in tone nor false or misleading; and the PI must be updated when new information becomes available that causes the PI to become inaccurate, false, or misleading.1
There is a tension in this type of drug communication between being thorough (to provide all relevant information) and being concise (to acknowledge the audience’s limited time).2,3 One commentary suggested that there is a need to clarify the information in the PI for clinicians regarding drug benefits and harms.4 Other commentaries have suggested that more can be done to simplify the DRUG INTERACTIONS section of the PI and make it user-friendly for busy prescribers who may not have the time or pharmacological expertise for full comprehension.5,6 The PI is developed by the pharmaceutical company and reviewed and approved by FDA in accordance with labeling regulations and guidance recommendations. However, since the PI is written for the healthcare provider, it would be useful to understand how the intended audience interprets the PI and if there are physician preferences for how information is communicated in the PI.
In addition, it is unclear how healthcare providers access and use the PI, and if they consider some PI content to be more useful than other content. Available literature offers evidence of prescriber behavior,7, 8, 9 prescribing errors,10, 11, 12 and prescriber understanding of risk information,13 whereas only a few studies have directly examined prescriber perceptions of the PI.14,15 One study noted that the sections in the PI that physicians found to be most useful were those with practical implications for their prescribing decisions like the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, and CONTRAINDICATIONS sections.14 That study also presented initial evidence that viewing certain sections of the PI was associated with physicians’ drug perceptions and prescribing intentions.
This study explored physicians’ perceptions or interpretations of specific information in five parts of the PI: INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and DRUG INTERACTIONS. To provide context for the findings on physicians’ interpretation of language in the PI, the current study began by assessing (1) whether the PI is a regular source of drug information for physicians, (2) how and when physicians access and use the PI, and (3) physicians’ perceptions of the PI.
Section snippets
Methods
Seventy one-on-one online interviews were conducted with primary care physicians (PCPs) (n = 35) and specialist physicians (n = 35). Individual interviews are valuable when exploring individuals’ opinions, attitudes, and behaviors because they elicit detailed responses that can be difficult to capture in large surveys.16, 17, 18 They also allow more in-depth discussion by each participant than would be possible in a survey or even a focus group.
Participant characteristics
Interviews were conducted with 70 physicians: 35 PCPs (including family practice, internal medicine, or general practitioner) and 35 specialists from 12 different medical specialties: obstetrics and gynecology (n = 5), pediatrics (n = 4), psychiatry (n = 4), critical care (n = 1), emergency medicine (n = 2), oncology/hematology (n = 3), neurology (n = 3), rheumatology (n = 3), orthopedics or sports medicine (n = 3), gastroenterology (n = 2), allergy/immunology or infectious disease (n = 2),
Discussion
This study used in-depth interviews to investigate how physicians use and perceive the FDA-approved PI for prescription drugs as well as physicians’ preferences and understanding for specific PI content and format. This study yielded several noteworthy findings regarding these topics.
First, consistent with findings from past studies, this study found that physicians used a variety of sources to look up drug information.25, 26, 27, 28 Notably, the PI was not listed as a top source of
Conclusion
This study offers new insights regarding physicians’ perceptions of the FDA-approved PI. These findings suggest that physicians may prefer the addition of clarifying language in two sections of the PI: (1) specifying the approved age groups in the INDICATIONS AND USAGE section even for medical conditions or diseases that are known to primarily occur in a specific age subgroup, and (2) explicitly stating “with or without food” in the DOSAGE AND ADMINISTRATION section for drugs used orally that
Funding
This research was funded by a contract from the US Food and Drug Administration.
CRediT authorship contribution statement
Helen W. Sullivan: Conceptualization, Methodology, Supervision, Writing – original draft. Claudia Squire: Formal analysis, Investigation, Methodology, Supervision, Writing – original draft. Kathryn J. Aikin: Conceptualization, Methodology, Writing – review & editing. Janice Tzeng: Formal analysis, Investigation, Writing – review & editing. Kate Ferriola-Bruckenstein: Formal analysis, Investigation, Writing – review & editing. Eric Brodsky: Conceptualization, Methodology, Writing – review &
Declaration of competing interest
None.
Acknowledgments
We would like to thank Joseph Grillo, Iris Masucci, Mongthuong Tran at the US Food and Drug Administration for their help developing the research questions and study materials. We would also like to thank Sarah Ray, Molly Lynch, and Christine Davis at RTI International for help with data collection and Micaela Brewington at RTI International for help with data collection, coding, and analysis.
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