Political ploys, Trump leadership gaffes hurt coronavirus fight, UC Davis Health CEO says
In an interview this week, the chief executive officer of Sacramento’s leading health system said that testing supplies remain woefully inadequate because of a lack of national leadership and that President Donald Trump’s political gamesmanship is keeping commonsense public health advice from helping Americans.
UC Davis Health CEO Dr. David Lubarsky discussed his insights into — and concerns about — the COVID-19 pandemic as Californians crosses six months of restrictions and lockdowns that have shuttered businesses and upended lives. Gov. Gavin Newsom issued the shelter-in-place order on March 19.
“We started out six months ago without a firm understanding of transmission, prevention of transmission and how we should approach this disease,” Lubarsky said. “Unfortunately, we now have a pretty good idea of how it’s transmitted and how to prevent transmission, but we have no clear leadership around instituting (strategies on) either of those two things.”
‘Woefully inadequate testing’
Lubarsky said UC Davis Health has the capability to run 2,000 COVID-19 tests a day and could turn them around in three hours, but it is running only 200 daily because of a shortage of testing supplies.
“The supplies go to national testing labs because of inappropriate decisions around how to prioritize where test supplies are routed,” he said. “We need a full-bore management of testing supplies and capacity to meet the need.”
Medical providers should have a rapid, reliable diagnostic kit similar to the one they have for influenza, that allows them to deliver news at the point of care, whether that’s at the hospital bedside, in the emergency department or at a doctor’s office.
“We started out with woefully inadequate testing,” Lubarsky said. “We still have woefully inadequate testing that we can actually perform at scale. ... That would actually allow people to decide to self-quarantine in a timely fashion to stop spreading it among their acquaintances and loved ones.”
The Trump administration has frequently touted its testing program, claiming that the widespread availability of coronavirus tests has revealed a more widespread pandemic than would otherwise be known. But top infectious disease experts advising the president have called the lack of rapid coronavirus testing “unacceptable” at this stage of the outbreak.
“When you look at what we’ve done on testing, in terms of the technology and the amount, it’s been really amazing,” Trump told reporters at a press briefing on Wednesday. “In fact, I think we’re going to crack 100 million tests very soon, in the very near future. We’re going to be cracking 100 million tests.”
It is still difficult to get a place in line to get a test due to supply shortages, Lubarsky said. Artist Kathrine Lemke Waste and other Sacramento residents have contacted The Sacramento Bee to complain that they had to wait three weeks, well past the 14-day quarantine period, to get test results.
The lack of national leadership in this area stands in stark contrast to what is happening in terms of scientific advancements in understanding this novel disease, treating it and reducing the loss of life.
Nearly 200,000 people in the United States have died so far this year as a result of COVID-19 infections. Roughly 15,000 of those deaths occurred in California.
So much was unknown in the beginning: How was this respiratory illness transmitted? Did it linger in the air? Could you get it by touching your grocery packages? What were the best ways to treat it?
“We’re pretty clear now, as UC Davis Health initially suggested after a very detailed review of the literature that transmission is primarily and overwhelmingly due to respiratory droplets that is, sneezing, coughing, shout, scream, sing, basically spit on people,” Lubarsky said. “If you do that enough that others inhale or ingest those respiratory droplets, then (they) may get sick, and it seems to be dependent on how much of the virus (they’re) exposed to, which is why casually passing by someone on the street without a mask means nothing whereas sitting in a small room with inadequate ventilation over lunch and a spirited conversation may indeed mean something.”
Vaccine distribution challenge
Lubarksy, an anesthesiologist, did his medical internship during the height of the AIDS epidemic, and he recalled how little was available in the way of treatment in the early stages of that epidemic.
“We still don’t have a vaccine for HIV,” he said. “So, the fact that we have five potential vaccine candidates now is truly an amazing turnaround in terms of a disease that has the potential to kill and infect large numbers of people.”
While the progress for therapies has been less dramatic than Lubarsky said he hoped for, medical research has provided clarity on treatments and protocols.
Doctors now know the time-frame in the disease progression when steroids can be life-saving rather than life-threatening, he said, and the antiviral remdesivir has been shown to help in recovery for the sickest patients, shortening their hospital stays.
In the early months of the pandemic, U.S. doctors were using more-invasive ventilation equipment to ensure patients got enough oxygen to keep their organs from failing, Lubarsky said, but they learned that those ventilators actually exacerbated inflammation and increased the risk of death.
So, he said, they turned to less-invasive forms of oxygenation and began to take advantage of the natural benefit of having patients lie on their bellies. The prone position allows oxygen to move more deeply into the lung’s tiny air sacs where oxygen transfer to the blood happens.
Hundreds of clinical trials are going on, investigating a variety of existing and new treatments for COVID-19, Lubarsky said, and he’s confident more treatments that will come to reduce both the mortality and level of morbidity that people suffer when they get COVID-19.
What concerns him, though, is the lack of trust that Americans have for sound advice from medical experts and for the federal regulatory checks and balances that vaccine manufacturers are undergoing, he said.
The head of the U.S. Centers for Disease Control and Prevention, Dr. Robert Redfield, gave testimony at a congressional hearing Wednesday, Lubarsky explained, “saying it’s more important probably over the next six months to wear a mask than getting out a vaccine will be because we have the difficulty of distribution and uptake.”
Redfield also said the public would not likely see widespread dissemination of a vaccine until the second or third quarter of 2021.
While Trump described both of Redfield’s comments as ”incorrect information,” Lubarsky said the CDC director’s testimony was both “sane” and “appropriate.”
“We would have to vaccinate or otherwise protect a couple hundred million Americans before we get to herd immunity,” he said, “and not everyone is willing to take the vaccine, so it will be very difficult to get to that level in a short period of time. He (Redfield) was accurate in that -- and was then chastised and made to retract that statement by President Trump because that did not fit with the political calculus.”
After criticism from the president, Redfield later issued a statement saying that one of the vaccines would likely be approved and ready for distribution before the end of this year.
Speaking with reporters on Thursday, Mark Meadows, the White House chief of staff, said that he believed Redfield spoke out of line because he is “not closest to the decision-making, as it relates to the Phase III clinical trials and the distribution thereof.”
“Generally speaking, speed of development and speed of distribution is not the strong suit for the CDC,” Meadows said, “and we saw that going back to the early days of the testing regimen that was put forth.”
In May, the Trump administration launched a federal interagency program called ‘Operation Warp Speed’ with the goal of discovering, manufacturing and distributing a coronavirus vaccine by the end of the year. The CDC is a part of that effort, and Redfield, whom Trump appointed in 2018 to lead the CDC, sits on the White House coronavirus task force.
Addressing health disparities
What health system CEO’s and the general public need from the CDC is “consistency, clarity and science — not politics,” Lubarsky said.
He pointed to surveys showing that fewer than 30 percent of Americans had enough faith in the U.S. regulatory approval process at this point to definitely accept a vaccine, if offered, Lubarsky said.
Just this week, a number of African Americans took to social media to excoriate the presidents of the historically Black universities Xavier and Dillard who encouraged students at their schools to participate in clinical trials for COVID-19 vaccine candidates to ensure its efficacy and safety for African Americans.
In his medical career, Lubarsky said, he participated in administering drugs and placebos as part of many clinical trials. In the double-blind trials, manufacturers tell neither the doctors nor the staff whether patients are receiving the drug candidate or the placebo, and patients are randomly assigned codes that determine which they will receive throughout a trial.
Lubarsky said he’s seen trials identify potentially allergic reactions, information that’s crucial to know and address. In Lubarsky’s experience, such complications or responses have rarely been life-threatening for the healthy individuals recruited to participate in the trials.
“We desperately need minority candidates who, because they traditionally don’t go to the fancy medical practices, they’ve been excluded,” Lubarsky said. “That means when something is judged safe and effective, it may be missing an important complication or an inadequate response in certain demographics.”
Documents recently released by the CDC and the U.S. Department of Health and Human Services have said that the clinical trials are focused on collecting representative data from all at-risk groups, including African Americans and other people of color who have been disproportionately affected by the pandemic.
Those coordinating the Phase III clinical trials in partnership with the National Institutes of Health have set up a faith-based initiative to build trust with minority communities as the process unfolds.
“With Black, Latinx and American Indian/Alaska Native communities throughout the nation disproportionately impacted by COVID-19 disease and death, it is critical that clinical trials enroll — more accurately, prioritize — participants representative of these populations,” the COVID-19 Prevention Network, which is recruiting volunteers for the vaccine trials, said in a statement launching its faith initiative.
Finding trusted messengers
The vaccine that ultimately emerges from clinical trials and review by the U.S. Food and Drug Administration will go first to the groups that were optimally protected by the vaccine in the trials, according to CDC officials.
The CDC is also “already working with local partners and using trusted messengers to establish new partnerships and contain the spread of misinformation” on the coming vaccine, in a program called called “Vaccinate with Confidence,” according to an HHS document released to state governments this week. The agency has already consulted more than 150 organizations dedicated to addressing health disparities.
Lubarsky said that he’s “concerned that political considerations are going to make decisions that are correct more difficult” for regulators, but he said leaders of pharmaceutical companies know they have a degree of liability in either falsifying -data or taking shortcuts.
“In that sense, our tort system and our usually overwrought liability system actually place an important check on incorrect decisions,” he said. “There does seem to be a rush. Doing an emergency uses authorization for a vaccine to meet an ‘important date’ such as the election is unwise.’”
Lubarsky said he has a lot of faith in general in the structures of the federal government and that the FDA and CDC have so many people with integrity that he’s hopeful they will do what’s right.
This story was originally published September 18, 2020 at 12:33 PM with the headline "Political ploys, Trump leadership gaffes hurt coronavirus fight, UC Davis Health CEO says."
