FDA – watercress words by Dr Aletha

What Republicans propose about medical research, healthcare workers, the FDA, and veterans

Modern miracles involving genetics, the immune system, cures for deadly diseases, and more are in the research pipeline. This is the consequence of marrying significant investment, both public and private, with the world’s best talent, a formula that has for a century given the American people the world’s best healthcare.

In this post, I present sections of the 2016 Republican Party platform dealing with healthcare workers, medical research, the Food and Drug Administration (FDA), and veterans’ healthcare.

I have included a few links to other sites to provide context; they are not necessarily endorced by the party.

Protecting Individual Conscience in Healthcare

America’s healthcare professionals should not be forced to choose between following their faith and practicing their profession.

We respect the rights of conscience of healthcare professionals, doctors, nurses, pharmacists, and organizations, especially the faith-based groups which provide a major portion of care for the nation and the needy.

a physician extending a stethoscope toward a patient who is not visible

Advancing Research and Development in Healthcare

We are determined that it should continue to do so, especially as we confront new dangers like Ebola, Zika, Chikungunya, and antibiotic-resistant pathogens.

To continue our headway against breast and prostate cancer, diabetes, and other killers, research must consider the needs of formerly neglected demographic groups.

a drawing representing CRISPR — CRISPR-Cas9 is a customizable tool that lets scientists cut and insert small pieces of DNA at precise areas along a DNA strand. This lets scientists study our genes in a specific, targeted way. Credit: Ernesto del Aguila III, National Human Genome Research Institute, NIH

Republicans

call for expanded support for the stem cell research that now offers the greatest hope for many afflictions — through adult stem cells, umbilical cord blood, and cells reprogrammed into pluripotent stem cells — without the destruction of embryonic human life

urge a ban on human cloning for research or reproduction, and a ban on the creation of, or experimentation on, human embryos for research

believe the FDA’s approval of Mifeprex, a dangerous abortifacient formerly known as RU-486, threatens women’s health, as does the agency’s endorsement of over-the-counter sales of powerful contraceptives without a physician’s recommendation.

Putting Patients First: Reforming the FDA

The United States has led life sciences and medical innovation for decades, bringing millions of high-paying jobs to our country and helping Americans and people around the world live longer, healthier lives. Unfortunately, the continuously increasing burden of governmental regulation and red tape is taking its toll on our innovative companies, and their pipeline of new life-saving devices and drugs to our nation’s patients is slowing and diminishing.

Collage of Various Types and Colors of Medication

The FDA-Food and Drug Administration– has slowly but relentlessly changed into an agency that more and more puts the public health at risk by delaying, chilling, and killing the development of new devices, drugs and biologics that can promote our lives and our health.

The FDA needs leadership that can reform the agency for our century and fix the lack of predictability, consistency, transparency and efficiency at the agency.

The FDA needs to return to its traditional emphasis on hard science and approving new breakthrough medicines, rather than divert its attention and consume its resources trying to overregulate electronic health records or vaping.

We pledge

to restore the FDA to its position as the premier scientific health agency, focused on both promoting and protecting the public health in equal measure, so we can ensure that Americans live longer, healthier lives,

that the United States remains the world leader in life sciences and medical innovation,

that millions of high-paying, cutting-edge device and drug jobs stay in the United States,

that U.S. patients benefit first and most from new devices and drugs, and

that the FDA no longer wastes U.S. taxpayer and innovators’ resources through bureaucratic red tape and legal uncertainty.

We commend those states that have passed Right to Try legislation, allowing terminally ill patients the right to try investigational medicines not yet approved by the FDA. We urge Congress to pass federal legislation to give all Americans with terminal illnesses the right to try.

Honoring and Supporting Our Veterans: A Sacred Obligation

Our wounded warriors, whether still in service or discharged, deserve the best medical care the country can provide. We must make military and veterans’ medicine the gold standard for mental health, traumatic brain injury, multiple traumas, loss of limbs, and post-traumatic stress disorder (PTSD). Those injuries require a new commitment of targeted resources and personnel for treatment and care to advance recovery.

disabled veteran patch — Photo by Dr Aletha

The VA- Veterans Administration

That includes allowing veterans to choose to access care in the community and not just in VA facilities, because the best care in the world is not effective if it is not accessible.

We will seek to consolidate the VA’s existing community care authorities to make a single program that will be easily understood by both veterans and VA healthcare providers.

Like the rest of American medicine, the VA faces a critical shortage of primary care and mental health physicians. That’s why there are long waiting times to see a doctor and why doctors are often frustrated by the limited time they have with their patients.

This is especially the case with mental health care, which often amounts to prescribing drugs because there are not enough psychologists and psychiatrists to do anything else. Inadequate treatment of PTSD drives other problems like suicide, homelessness, and unemployment.

This situation may not be quickly reversed, but a Republican administration will begin, on day one, to undertake the job.

Over-prescription of opioids has become a nationwide problem hindering the treatment of veterans suffering from mental health issues. We therefore support the need to explore new and broader ranges of options, including faithbased programs, that will better serve the veteran and reduce the need to rely on drugs as the sole

exploring the HEART of healthcare policy

Medical stethoscope and heart on a textured background

Dr Aletha

Here is another post in this series you’ll want to read also.

The Republican Party-Addressing Tort Reform, Drug Abuse, and Disabilities

We support state and federal legislation to cap non-economic damages in medical malpractice lawsuits, thereby relieving conscientious providers of burdens that are not rightly theirs and addressing a serious cause of higher medical bills.

Keep reading

August 8, 2022August 20, 2022

from 1776 to 2020-a vision for a “more perfect Union”

The United States’ healthcare system combines public health efforts with mostly private delivery of health care. Usually they coexist side by side with some but infrequent interaction. The public health emergency created by the pandemic forced them into a “union” that quickly became politicized, and unfortunately diminished the effectiveness of the response.

In ophthalmology, visual acuity is measured by the distance one can see compared to “normal”. A person with 20/80 vision can see at 20 feet what a normal vision person can see from 80 feet. Perfect vision is labeled 20/20.

Maybe you expected 2020 to be a perfect year. I doubt that any of us would say it was. The year brought

a contentious presidential election and an unexpected serious pandemic
peaceful protests and raucous riots
racism confrontations and reconciliation pursuits
health inequities battles and healthy community pursuits

This next year 2021 has already had its share of problems, but I think most of us feel calmer, more hopeful, and eager to resume many of the activites we put on hold last year. And that includes a 4th of July celebration.

Statue of Liberty — Lady Liberty lifting her torch in New York harbor

Independence Day, July 4

Every year on July 4th the United States celebrates Independence Day- the day in 1776 the original 13 American colonies established an independent country.

A few years later they established a government as specified in the Constitution of the United States, to “form a more perfect Union”.

The United States Constitution

The Constitution does not specifically mention, establish, create, or endorse a healthcare system. Some phrases in the Preamble hint at it though-

establish Justice
insure domestic Tranquility
provide for the common Defense
promote the general Welfare

Government sponsored health care programs

The Affordable Care Act, aka Obamacare

The United States Congress passed the Patient Protection and Affordable Care Act (ACA) in 2010 to guarantee basic health insurance to all citizens. During his term in office, President Trump vowed to “repeal and replace” this law but although it has been modified, it is still in place.

Healthcare for military service members, veterans ,and their families

During the American Revolution the fledgling government extended health care benefits to the soldiers and veterans of that war; that system evolved into the current Department of Defense military health care system which covers service members and the Veterans’ Administration system for veterans.

a Veterans Administration clinic (photo by Dr. Aletha)

American soldiers serving in Afghanistan

Medicare and Medicaid

Two other government healthcare programs- Medicare and Medicaid are over 50 years old.

Medicaid provides insurance coverage for adults and children who are unemployed or low income.

Medicare covers disabled children and adults and persons 65 years and older.

a senior adult couple relaxing in lawn chairs — by Brayden Heath from LIGHTSTOCK.COM

Department of Health and Human Services

Most of the health care activities of the federal government fall under the agencies of the Department of Health and Human Services or HHS. The Secretary of HHS serves in the President’s Cabinet.

Due to the COVID-19 pandemic, we’ve heard more about the HHS in the news than usual; maybe you’ve never heard of these agencies. Generally, management of a pandemic or other public health emergency falls within the work of the CDC.

Centers for Disease Control and Prevention–

The CDC’s mission is simple but encompasses many facets of health

“to work 24/7 to protect America from health, safety and security threats, both foreign and in the U.S.”

The CDC website devotes an entire section now to information, guidelines, and news about the SARS-CoV-2 virus and COVID-19.

illustration showing the coronavirus which causes COVID-19

The goal of public health is to avoid or prevent health threats from becoming public health emergencies, like the COVID-19 pandemic. If they accomplish the mission, we hardly notice. But when an outbreak occurs, their work suddenly becomes visible, scrutinized, and debated.

The CDC director, Dr. Robert Redfield, spoke to Congress soon after the pandemic started, and his assessment of the response and funding for it were not positive. Lack of funding hampered the federal government’s response to the coronavirus outbreak, he told lawmakers on March 10, 2020.

“The truth is we’ve underinvested in the public health labs,There’s not enough equipment, there’s not enough people, there’s not enough internal capacity, there’s no search capacity”
Dr. Robert Redfield, Director, CDC

The Trump administration subsequently enlisted private companies to help cut the difference. The CDC partnered with Integrated DNA Technologies to manufacture the COVID tests under a CDC contract. IDT partnered with commercial labs for the testing.

2021-the Biden Administration

On December 7, 2020 President Biden’s transition team announced that Rochelle P. Walensky, M.D. was slated to become the new director of the Centers for Disease Control and Prevention. In a 2021 interview she talked about the “big questions that keep her up at night.”

How are we going to ensure that the people who are hardest to reach with COVID vaccines receive it?

How are we going to ensure that when everyone else is not thinking about COVID we are still leveraging the infrastructure and connections we’ve made and that we address the collateral damage of this pandemic: the hypertension , the pediatric vaccinations that haven’t happened, HIV control?

How are we going to address a resurgent opioid crisis that I thought I’d never see again?

How are we going to address gun injury prevention?

How do we not only protect this nation, as we realize that we need to protect the world, too. Not just for humanitarian purposes, but because we are so integrally linked, as this virus has taught us.

National Institutes of Health– NIH

The National Institutes of Health, part of the Public Health Service,

supports biomedical and behavioral research with the United States and abroad,
conducts research in its own laboratories and clinics,
trains promising young researchers, and
promotes collecting and sharing medical knowledge.

And within the NIH is the NIAID– the National Institutes of Allergy and Infectious Diseases, which has been an invaluable source of guidance as the United States and the world works to understand and manage this new infectious disease.

President Donald Trump Visits NIH — President Donald Trump visited NIH on March 3, 2020 and toured the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC) to learn about research on a vaccine for the novel coronavirus SARS-CoV-2. From left: VRC Deputy Director Dr. Barney Graham, NIH Director Dr. Francis Collins, VRC Director John Mascola, Department of Health and Human Services Secretary Alex Azar, President Trump, and VRC Research Fellow Dr. Kizzmekia Corbett.
credit NIH, public domain

Novel Coronavirus SARS-CoV-2 — This scanning electron microscope image shows SARS-CoV-2 (orange)—also known as 2019-nCoV, the virus that causes COVID-19—isolated from a patient in the U.S., emerging from the surface of cells (green) cultured in the lab.

Credit: National Institute of Allergy and Infectious Diseases-Rocky Mountain Laboratories, NIH

President Biden Visits NIH Vaccine Research Center — NIH immunologist Dr. Kizzmekia Corbett speaks to President Joe Biden about the fundamental research that contributed to the development of the Moderna and Pfizer COVID-19 vaccines when the President visited NIH’s Vaccine Research Center on February 11, 2021. Credit: NIH/Chiachi Chang

Food and Drug Administration– FDA

The FDA joins the pandemic response by

reviewing and approving diagnostic tests for the coronavirus
protecting consumers from fraudulent products for COVID-19.
issuing Emergency Use Authorizations (EUAs) for ventilators
sampling and testing of respirators for importation

Late in 2020 the FDA gave Emergency Use Authorization to 2 vaccines against COVID-19. By December Americans began receiving “shots in arms”, a welcome step in returning to normal.

COVID-19 Diagnostic Test Attire — FDA Commissioned Corps officer RADM Estella Jones, DVM, OCET Deputy Director and Co-Chair of the FDA Animal Welfare Council, oversees Commissioned Corps officers as they practice proper fitting of protective items. Healthcare workers testing patients for COVID-19 novel coronavirus infection must wear specific protective gowns, gloves, ventilation masks, and full facial shields as shown, and must replace these items after each patient is tested. credit FDA, public domain

Occupational Safety and Health administration-OSHA

OSHA is part of the United States Department of Labor. OSHA’s administrator answers to the Secretary of Labor, who is a member of the cabinet of the President of the United States.

Congress created the Occupational Safety and Health Administration (OSHA) in 1970 to

ensure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance.

For the pandemic response, OSHA offers guidance on

returning to work
preparing workplaces for COVID-19
worker exposure risk to COVID-19
for specific industries including airlines, farms, retail, corrections
use of respiratory protection equipment

important laws that administer and regulate both private and public healthcare.

The Affordable Care Act- ACA

Health Insurance Portability and Accountability Act-HIPPA

Emergency Medical Treatment and Labor Act- EMTALA

Americans with Disabilities Act-ADA

Family Medical Leave Act-FMLA

replica of the Liberty Bell at Disney World, Florida, photo by Dr. Aletha

Let Freedom Ring

In the Declaration of Independence, the founders of the United States created a nation based on the “self-evident truths” of “Life ,Liberty, and the pursuit of Happiness” and to promote “Safety and Happiness” .

They didn’t mention “healthcare” either, maybe because in the late 1700s medical practice was more superstition than science.

Surgery was rudimentary due to no anesthesia and infections frequently proved deadly due to no antibiotics.

No one had even imagined, much less identified the human genome, and viral DNA-what was that??

I wonder if they intended their new government to spend so much time and money providing and regulating health care –most of which was not available or even imagined at that time?

Public vs Private-not a perfect Union

The United States’ healthcare system combines public health efforts with mostly private delivery of health care. Usually they coexist side by side with some but infrequent interaction.

The public health emergency created by the pandemic forced them into a “union” that quickly became politicized, and unfortunately diminished the effectiveness of the response.

But despite the lack of coordination and cooperation between all levels of government and private citizens, our health care professionals, in both public health and private medical practice stayed true to their calling. Many risked their own lives to care for COVID-19 victims. Others sacrificed time and finances to lead the pandemic response in their communities and on social media- maybe not perfectly, but definitely UNITED in resolve to lead, help, and heal their fellow citizens through this unprecedented health emergency.