Dr. Howard Koh knows what it’s wish to be a government official running an epidemic response.
In 2009, while he served as assistant secretary of health within the Department of Health and Human Services, the H1N1 flu virus was detected within the U.S. quite 60 million people within the U.S. were thought to possess contracted the novel sort of the influenza an epidemic , with a minimum of 12,469 people succumbing thereto .
While there are marked differences between a flu pandemic and this coronavirus pandemic, Koh thinks many of the teachings he learned back in 2009 are missing today.
“When crises occur, what people expect and deserve may be a one-government approach: federal, state and native officials working together to guard the American people,” Koh, now a professor of public health leadership at the Harvard T.H. Chan School of Public Health, said Wednesday during an interview. In 2009, “everybody saw that government was working together. And that’s what has been absent this point , and in my view has allowed this pandemic to persist for way too long.”
Dr. Howard Koh: With reference to vaccines, particularly, there’s a really well-described, carefully followed process for vaccines through [clinical] testing protocols, having them approved by the FDA, then disseminated broadly to the general public . That’s a process that’s been respected over variety of decades for an entire host of vaccines that have saved many lives. we’d like to carry the standards high now for any potential COVID vaccine.
Koh: This current vaccine effort is being conducted within the fastest timetable in history. Vaccines can sometimes take a decade, and this vaccine is being developed over a matter of months. along side speed, which is extremely much needed during a crisis like this, we also need attention to safety. and therefore the public must hear more about the eye to safety.
‘If we skip the science now, it could cost us many lives later.’
— Dr. Howard Koh
Koh: it had been fairly clear to me and lots of of my scientific colleagues that the info on [convalescent plasma’s] effectiveness wasn’t strong enough to proceed with an EUA. There are no definitive outcomes from randomized, placebo-controlled trials. The Mayo Clinic data that was delayed as justifying authorization were analyses where everybody got convalescent plasma and there was no control arm. They tried to mention that folks who got it earlier did better than those that got it later, and people who got higher doses did better than those that got the lower doses of antibodies. But that’s not the gold standard for creating definitive evidence.
At some point, randomized clinical trials are getting to attempt to answer [whether] patients receiving convalescent plasma do better than those that don’t. [But] it’s very hard to possess anybody comply with enter that trial because everybody will want the plasma, and nobody will want to be randomized through a placebo-controlled arm. This announcement, ironically, is impeding the science. If we skip the science now, it could cost us many lives later.
Koh: That’s the fear. An emergency use authorization isn’t approval. [FDA commissioner Dr. Stephen Hahn] did say that, in his defense. But I don’t think people understand that distinction immediately . the quality is far lower for issuing an EUA than a full FDA approval. during a time like this, where trust and confidence is everything, that bar possesses to be held really high.
Koh: Well, it’s true that the cases have dropped by a few third from the height in midsummer, but we still have an extended thanks to go. Hospitalizations have declined. Deaths are beginning to drop a touch bit. That reflects the sacrifices of many Americans to stick to those public health standards, and other people should be thanked and supported for following those new norms.
But we’ve got an extended thanks to go. In every step of this pandemic, our country has underestimated the tenacity of this virus and overestimated our ability to contain it. As a result, we’re into month eight of the “first wave” whereas numerous countries round the world got through this in two and a half to 3 months. We opened too early. We disappointed our guard. There’s not been a coordinated national strategy. Every state is pursuing their own strategy. And it’s led to the present protracted first wave.
People inquire from me regularly, is that this a second wave? and that i say, no, you’ve got a second wave by definition only the primary wave comes and goes. the primary wave has come and never left. Other countries are having small second waves [and] have aggressively tackled them during a way that our country has not. A second wave of COVID, plus seasonal flu, within the middle of faculties and colleges [reopening], are all converging for this fall, and that’s the difficulty before us.