Former FDA Commissioner: Better Days Coming, But Be Wary Of Holiday Gatherings

Former FDA Commissioner: Better Days Coming, But Be Wary Of Holiday Gatherings
Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy

With COVID-19 cases rising fast, the state and nation appear headed yet again for some dark times. But there are also better days ahead, a Duke health expert said Tuesday.

Dr. Mark McClellan, a former commissioner of the U.S. Food and Drug Administration who currently heads the Duke-Margolis Center for Health Policy, spoke to media Tuesday about the upcoming holidays, vaccine distribution, the effectiveness of a new monoclonal antibody therapy, and when life may, finally, get back to some semblance of normalcy.

Watch the briefing on YouTube.

Here are excerpts:

ON WHAT STATES AND PEOPLE SHOULD BE DOING RIGHT NOW

“Please try to follow the guidance we know works. People are very frustrated, tired, exhausted by the pandemic at this point. But we always knew this was going to be the toughest part heading into winter. Colder weather, people closer together.”

“We are not in control in any part of the country. In contrast to the previous two surges we’ve seen with COVID, one in April and one in the summer, this one truly is nationwide. It’s affecting different areas differently. Some areas, like El Paso, Texas, South Dakota and North Dakota, much of the mountain west, [are seeing] very rapid growth with health care systems that are at capacity or beyond.”

“We’re past the time when it’s important not only to encourage masks and distancing for individuals … but also to take some further steps, from state, local and perhaps federal standpoints, to encourage more use of the steps we know work.”

“President-elect Biden has talked about something like a national mask mandate. There are some limits on his authority to do that in areas under state and local jurisdiction. But I do think it’s time for every state and every mayor to be thinking about whether they’ve reached a level of lack of containment in their community where they have to pull back.”

“We’ve seen that restrictions on bars, nightclubs, restaurants … does lead to a significant reduction in local spread.”

“Restrictions on gatherings could be a good alternative, if done early enough, to complete lockdowns.”

“Limit interaction with groups, including over Thanksgiving, coming up and the other holidays coming up, until we’re past this, and back that up with some state, local and federal government support.”

“We’re definitely trending in the wrong direction right now.”

ON HOW PEOPLE SHOULD APPROACH UPCOMING HOLIDAYS AND FAMILY GATHERINGS

“A lot of people do want to see family members and friends. They’ve spent most of this year isolated, away from them. Many of us, me too, I’d love to see my mother. She’s older and has some health issues. We’re not going to be able to do it this year. We’re going to have to try out the Zoom approach.  I do think people should really consider what’s best for their loved ones, especially if they’re in a high-risk category or if they live with or interact with people who are.”

“This is how spread occurs. It occurs even if most of the cases now are in relatively younger people, 20s, 30s, who generally don’t have much symptoms. They do pass it along to others they come into close contact with.”

“Be careful about expanding your bubble. The bigger it gets, the more likely it is to burst.”

“This is just a bad year for getting together in groups.”

“The good news is this is probably the last big surge of this whole acute phase of the COVID-19 pandemic. There’s been remarkable progress on vaccines. Those aren’t really going to be kicking in in terms of reducing risk for a few more months, but it’s not that far away.”

“The months ahead are going to look better than the weeks ahead. If we can double down and try to contain this huge outbreak … things are going to start gradually getting better.”

ON A BEST-CASE SCENARIO FOR VACCINES

“We probably won’t have most Americans vaccinated until the second quarter or second half of 2021. Vaccines will start to be available later in December … for health care workers and people in nursing homes or in settings where they’re at high risk. That’s the first round, probably the first month or two.”

“Younger kids are not part of any of the vaccination testing going on now. So it’s going to be a while before most Americans are vaccinated.”

ON CONCERNS THAT VACCINE MAY NOT PROTECT PEOPLE LONG-TERM

“There is a gap in knowledge. It does look like the protection is going to last at least a few months. They are very, very likely to protect people for at least this acute phase of the pandemic. It doesn’t mean they’re perfect. It doesn’t mean everybody is not going to have symptoms. They may have milder symptoms.”

“What we don’t know, really, is will the immunity last substantially longer than say the next season, the next six months to a year? Will people have to get COVID booster shots every year or every five years?”

“We just don’t know. We’ll learn that based on the experiences people have.”

“It’s very plausible that we may need booster shots, not in the matter of a few months, but annually, every few years, or something like that.”

ON POTENTIAL USE OF MONOCLONAL ANTIBODIES FOR TREATMENT

“I think it’s a very promising treatment. … People who are older and are in risk groups, who started having symptoms that were getting worse, these monoclonal antibodies … they do have a significant effect on neutralizing the virus for people who are treated early.”

“The challenge now is really getting those monoclonal antibodies out to the patients who can benefit. We are not well set up in our health care system to do that.”

“This is a special treatment. It needs to be infused. It takes an hour. This is not just a shot in the arm. So we’re going to need to set up approaches in our health care systems and also for our high-risk populations … and set up special COVID infusion sites.”

“You can’t put patients getting infused for COVID, who are actively infectious, in the same place as say, a cancer patient or other people who benefit from monoclonal antibody infusions.”

“If we can get through the coming weeks, we have vaccines over the coming months that are going to gradually help prevent infection spread and reduce the likelihood of these spikes. We have a lot more availability of rapid testing. They’re being used by universities, sports leagues, ‘Saturday Night Live,’ other workplaces where people have to be together. Those could be more widely available.”

“2021 can look a lot different than right now in terms of the impact of COVID.”

(NOTE: Given fast-moving developments regarding COVID-19 monoclonal antibodies, Duke-Margolis is releasing a suite of issue briefs and working papers this week aimed at helping policymakers and senior leaders plan for the availability of these treatments. This brief examines the critical near-term challenges facing patients, providers and payers – including recommendations on how best to adapt timely testing and referral protocols, specialized infusion capacity, payment for administration, state-guided allocation to specialized infusion sites, and our overall supply of these treatments. Additional papers in coming days will focus on patient identification and prioritization, payment models, and additional evidence development needs.)

ON WHETHER THE FOOD AND DRUG ADMINISTRATION SHOULD BE AN INDEPENDENT AGENCY

“I think it’s something the new administration should consider. We’re going to have a deep look at everything that could have been done better in dealing with this pandemic as we start to get through it more. That should be a big focus area for Congress and the administration in 2021.”

ON WHAT NORTH CAROLINA AND INDIVIDUAL STATES SHOULD BE DOING RIGHT NOW RE: COVID

“There are a lot of states that are taking important steps, starting with mask mandates. I don’t think the country needs to go back to a full lockdown everywhere. The impact of the disease is different from place to place.”

“North Carolina, while our trends overall are concerning in terms of rising cases, it is not as bad as many parts of the country where we’re seeing cases skyrocketing out of control. Hopefully with some limited further measures – avoiding spreader events over the upcoming holidays … we won’t have to go further. We need to be really vigilant in every part of the country.”

ON WHAT STATES SHOULD BE DOING TO PREPARE FOR VACCINE DISTRIBUTION

“The very first round of distribution in December is mainly going to be through hospitals, health care facilities, for their own workers. The states need to make sure every health care organization is thinking about and has a plan for how they’re going to distribute and use the vaccine for their own workers, and how they’re going to educate and engage them on the risks.”

“These are our highest-risk workers. They’ve been on the front lines and many of them have had to suffer through COVID.”

“The bigger role for states is going to come in January and into February and March … when we move into broader access with more vaccines being available. There is a lot of work for states to do from that standpoint. To engage everybody in all their communities around the information, clear, accurate information on the vaccines and their potential benefits and risks.”

“Ways to get access to the vaccine conveniently in all neighborhoods and all communities … particularly in areas that are typically underserved. It’s probably not going to be sufficient to ask people to go to the doctor or maybe even the pharmacy, although pharmacies are going to be a big part of this distribution.”

“All that needs to be accompanied by good, transparent, clear information.”

Meet the expert:
Dr. Mark McClellan is a physician and economist who directs the Duke-Margolis Center for Health Policy, where he works on strategies and policy reforms to improve health care. He was commissioner of the U.S. Food and Drug Administration and administrator of the Centers for Medicare & Medicaid Services. 

Disclosure:
Dr. Mark B. McClellan is an independent director on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and receives fees for serving as an adviser for Arsenal Capital Partners, Blackstone Life Sciences, and MITRE.