Save Our Science-Based Federal Agencies, Our Lives Depend on Them
The current COVID-19 pandemic is putting unprecedented pressure on our nation’s health care system and the people who rely on that system for life-saving care.
From viral hepatitis to liver transplantation, liver cancer to Nonalcoholic Steatohepatitis (NASH), liver disease patients rely on science for the development and approval of therapies to effective public health strategies. This crisis has shown the need to reinforce and even build upon that strong scientific foundation has never been more urgent.
The risks for patients impacted by liver disease become even more apparent when we take into consideration that recent research has found increased mortality rates from COVID-19 among people with chronic liver disease and cirrhosis. Many, including Admiral Brett P. Giroir, M.D., Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS), have also called for patients with worsening liver function to be tested for coronavirus. The Centers for Disease Control and Prevention (CDC) underlined this same point, and released new resources addressing concerns related to COVID-19 and liver disease.
Outside of liver disease specifically, the CDC also reports that in the US alone, over 40% of adults have delayed or forgone medical treatment during the pandemic, including 12% who have delayed emergency medical care. Also, about ⅓ of the country has delayed routine care, such as treating chronic medical conditions or receiving wellness checks to detect new illnesses. Even amid a pandemic, our public health infrastructure needs to remain operational and effective; therefore, it's paramount the federal government continues to invest in public health and value evidence-based science above all else.
Whether directly from COVID-19 or as a consequence of the burden of the pandemic on our health systems, lives are at risk. Adequate steps must be taken to ensure that people are not disproportionately impacted, and do not experience healthcare or treatment disruptions. However, even with the harsh reality for immunocompromised patients, and patients with liver disease, the U.S. Federal government appears to have their priorities mixed up.
It is important for the patient community and the country as a whole to be clear:
No, to achieving herd immunity by reopening in a manner that allows unbridled spread in an environment with no treatment and no vaccine.
No, to pressuring Federal Agencies to redraft evidence-based health guidance or scientifically determined approvals to fit political agenda or timelines.
Yes, to recognizing the harms from the lack of investment in public health infrastructure, staffing, stock, and preparedness planning and a commitment to do better in the future.
No to Stripping Federal Agencies of Science
Several reports detailing emails between President Trump appointees, such as the HHS public Affairs Chief, Michael Caputo and his Scientific Adviser, Paul Alexander, and the CDC acting Director, Robert Redfield, have recently surfaced. These emails call for the CDC to allow outside personnel to have the final say on draft MMWRs concerning COVID-19. These changes were supposedly made to align with President Trump's optimistic messages about the pandemic, and included everything from rewording phrases to altering mortality data. Although the CDC is a federal agency, its operational procedures and recommendations should be nonpartisan at all times, and altering the MMWR in any way to appease those in power should not be tolerated.
Due to the importance of protecting the public health, it is concerning to see some of these recent reports. The U.S. federal agencies supporting public health programs—including the National Institutes of Health (NIH), National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Centers for Disease Control and Prevention (CDC)—are leading to better health and well-being for people across the nation. We can not afford to strip these agencies of critical science or pressure these vital agencies during this pivotal time, our lives depend on it.
No to Herd Immunity
Another threat to public health is the idea of herd immunity. In April, Scott Atlas, a neuroradiologist at Stanford's Hoover Institution with no epidemiological experience, spoke publicly about utilizing herd immunity to combat COVID-19 in the U.S. This would entail the majority of citizens contracting the virus, hoping that the country would reach a critical mass where those who did not become infected, notably the elderly and those at high risk for acute illness, are subsequently protected.
I can not stress enough that herd immunity is a NO go. Who has the right to decide who lives or dies? No amount of lives lost is acceptable!
Experts are unsure what percentage of the population would need to be infected to reach herd immunity; estimates range from 20-70%, but WHO's chief scientist Soumya Swaminathan believes it will take closer to 65-70%. This would mean in the US, 2.13M people would die, assuming a fatality rate of 1%! Surviving does not equal thriving! The CDC reports that roughly ⅓ of people aged 18-34 who have "recovered" from COVID-19 are still suffering health effects weeks or even months later. Finally, a population has never in history benefited from herd immunity through natural infection, only by administering a vaccine.
No to Pressuring Federal Agencies
At the forefront of everyone's mind is the potential for a COVID-19 vaccine, but as the U.S. ramps up several phase 3 trials, questions about whether people would even get vaccinated have arisen.
In August, 78% of Americans reported their concerns that the vaccine approval process is driven by politics rather than science. Shortly after, nine leading pharmaceutical and biotechnology companies pledged to present a vaccine to the Food and Drug Administration (FDA) only once the safety and efficacy have been verified to the fullest extent via a successful phase 3 trial, but there was no mention about the need for transparency.
On top of this, over the past few weeks the White House decided to halt the release of new FDA standards for emergency authorization of a COVID-19 vaccine. President Trump has consistently emphasized, and even gone so far as assuring that a vaccine will be available before the November election. This consistent pressuring by President Trump only underlines the real concerns of tampering and politicizing FDA processes. In response, the FDA has continued to tell coronavirus vaccine developers that it will hold them to strict standards for emergency authorization. Thankfully the White House just recently approved these new standards, but only after the FDA unilaterally published the guidelines on its own website.
If a future vaccine is going to be safe, effective, and accepted by the public, the process through which it is developed, tested and approved needs to be established, consistent, clear and transparent. The process should be independent of any parallel events, such as the Presidential election, and should not be rushed to satisfy a political agenda. The FDA as a regulator needs to be supported, not pressured to approve an unsafe option. The mission of the FDA to protect the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. The FDA needs to be allowed to follow through on this mission. They have a vital role to play in protecting the lives of Americans, and must be allowed to ensure there is sufficient oversight of all trials. This action is critical to secure the health and well-being of all people who are at risk of COVID-19.
Yes to Investing in Public Health
In a sea of no's, we need to continue to say yes to investing in public health. We need to ensure medical treatments are available and accessible throughout the pandemic. We need to ramp up COVID-19 testing, including asymptomatic individuals who potentially make up 40% of active infections, to understand the disease's spread and magnitude. Most of all, we need to listen to evidence-based science and medical professionals such as those who recently spoke during the 20/3/1 series at Research!America’s 2020 National Health Research Forum, even if their voices are becoming increasingly difficult to hear.
The U.S. Congress must act quickly to strengthen all critical relevant federal agencies. The portfolios of these crucial federal agencies include vital research and prevention programs that save countless lives. Many of the programs’ award mechanisms propel the exploration of revolutionary ideas and concepts. These agencies can have a significant impact upon both their respective fields of research and support and treatment of all Americans especially during a global crisis.
Instead of working to suppress these vital federal agencies, we must support them! We can not afford to fight on partisan lines any longer. Haven’t we seen enough lives lost over the months of this global pandemic? The U.S. Congress must act quickly to approve the next COVID response package to protect these agencies, and save lives!
If you are interested in taking a more active role with Global Liver Institute on these critical issues, please join the liver advocacy community and learn about upcoming opportunities to advocate on behalf of all individuals impacted by liver disease, and save our science-based federal agencies.
Donna R. Cryer
Founder & CEO
Liver Transplant 1994 Johns Hopkins