番茄社区app

In this exclusive video interview, 番茄社区app editor-in-chief Jeremy Faust, MD, talks with Admiral Rachel Levine, MD, the assistant secretary for health at the Department of Health and Human Services (HHS), about how HHS is addressing the increases in neonatal syphilis and maternal morbidity and mortality in the U.S.

The following is a transcript of their remarks:

Faust: Hello, it's Jeremy Faust, editor-in-chief of 番茄社区app. I'm so happy to be joined today by Dr. and Admiral Rachel Levine.

Admiral Levine is the 17th assistant secretary for health for the U.S. Department of Health and Human Services, HHS, and the head of the U.S. Public Health Service. She is one of the few openly transgender federal government officials, and one of the first to hold an office requiring Senate confirmation.

Admiral Levine, thank you so much for joining us.

Levine: I'm very pleased to be here. Thank you.

Faust: A lot of people wanted me to ask about this syphilis increase. There's really been an increase in neonatal syphilis in this country, and studies show that a lot of these can be prevented with better testing. So where are we on this, and how can HHS get involved?

And I'll just throw in that there's a double-edge of stockpiling, right? If you stockpile, you're hoarding, but if you don't get the pipeline going, there's no medication.

Levine: You are entirely correct that the United States is part of the global increase in syphilis that we have been seeing over the last 8 years or more. There were very few cases of syphilis in the United States in 2000. It represented a global decrease, and we're seeing a global increase now. That has accelerated the United States over the last 3 or so years.

Syphilis is preventable and syphilis is treatable. This is a bacterial illness that is a sexually transmitted infection [STI]. So we are addressing this at HHS with a new, syphilis and congenital syphilis task force. This includes all of the different divisions at HHS as well as the VA and the Department of Defense.

We are looking at this from many different perspectives. We have six subcommittees looking at the statistics and the epidemiology and the prevalence of this, we're looking at prevention and testing and surveillance of this, we're looking at treatment, we're looking at specifically congenital syphilis, we're looking at the syndemic -- the clustering of different symptoms with hepatitis B, HIV, syphilis -- and the connection to substance use, particularly opioid use, as well as communications. Each of those has a subcommittee.

We are concentrating on 14 districts -- 13 states and the District of Columbia -- but we're of course working with all of the states and state health officials across the country looking to address this.

There are a couple of different opportunities and challenges. One of the opportunities is a relatively new rapid test for syphilis. It's not perfect, but I think it is an opportunity in terms of looking to address the syphilis crisis that we're seeing now.

The other opportunity is a draft proposal, which will soon be a sort of standing recommendation of what is called DoxyPEP. That means doxycycline, an oral antibiotic, post-exposure prophylaxis that after someone engages in what could be risky sex for an STI -- including syphilis -- you can take two pills of doxycycline and prevent something like chlamydia and syphilis, sometimes gonorrhea, although there's some gonorrhea resistance.

The challenge is a global shortage in the standard-of-care treatment for syphilis, which is a type of penicillin. This is made for the United States and many other countries by Pfizer, and the FDA is speaking with them and working with them to try to ramp up production. We are hopeful for an increase in production later this year.

In response to that, the FDA has worked with a French company to allow the importation of another preparation of penicillin called Extencilline [benzylpenicillin benzathine]. That is available in the United States.

There is also a doxycycline protocol for treatment of primary and secondary syphilis. But the challenges are, of course, that pregnant women and other pregnant people can only have those shots of penicillin, and of course newborns with congenital syphilis require penicillin. So we are looking to address all of those factors and we're looking for process-oriented outcomes, but actually we're looking for outcome outcomes: less cases of syphilis and more cases of congenital syphilis prevented. We're looking for results by the end of the year.

Faust: I just want to highlight a few things that you said, including recent data showing that post-exposure prophylaxis using doxycycline is likely very effective and this is where we ought to be headed.

I also did want to flag the authorization to use the French formulation of penicillin, because this is always bandied about: why don't we import stuff? I support that when we need to. Is this something that we could do more of in the future, not just with therapeutics, but look at tests? In Europe, there are five-in-one rapid tests for the five big viruses that we care about -- well, we care about more than five -- but for five big viruses that we care about.

Is this a proof of principle for the direction we might be going?

Levine: Well, this is not brand new for the FDA, but I'll defer to the FDA in terms of their different processes and procedures. To be a fully-authorized medication, those companies have to go through quite a regulatory process, and the regulatory process is very important to make sure of the safety and efficacy of medications. So we'll see what the FDA can do in the future.

Faust: I know that it's not your job to represent Pfizer, but Pfizer does give us the penicillin we need. Why were they caught off guard? Why do we have a shortage?

Levine: Well, we have a shortage because of the global increase that they have not been able to keep up with. I don't know the details in terms of their production capacity, but it has not been able to keep up with the global increase of syphilis. So we're working with them to try to ramp up production.

Faust: Right. The context of that for the viewers is that there's been, I believe, a tenfold increase in the past 10 or 12 years from 300 [cases] in 2012 to 3,700 in 2022. So we're dealing with literally a tenfold increase.

Levine: And that's just congenital syphilis. There's been a significant increase. Of course, congenital syphilis is because pregnant women and other pregnant people have syphilis, so one leads to the other. The cases of primary and secondary syphilis in adolescents and adults, of course, directly relates to the potentially devastating cases of congenital syphilis.

So we are looking at this very broadly across the federal government, and we're going to do everything we can working with our state partners.

Faust: There's a real disconnect, isn't there, between how much this country spends on care and something like maternal outcomes. This is maybe part of that, but what are some of the other drivers of that that we could really look at in the next couple of years?

Levine: Well, it is a very important issue. Looking at maternal mortality -- women who pass away either right before, during labor, or in a period after labor -- has been increasing significantly in the United States.

We are the only developed country in the world that is having this type of increase. And as you dig down into the data, the increase is significant among Black and African American women as well as American Indian and Alaska Native women. It has significant issues in terms of health equity.

Now, health equity is fundamental to everything that we're doing at HHS and Secretary Becerra is very, very concerned about this increase of maternal morbidity and mortality. So we are looking at this also across the department -- our Office on Women's Health, at my Office of the Assistant Secretary for Health, HRSA [Health Resources and Services Administration] is leading the way in this, but CMS, CDC, NIH, and more.

We're trying to look at all the different things that we can do, both in terms of how maternal care is provided, but also looking at the social determinants of health -- those social factors that influence health that are not directly medical care-related.

So that would include, of course, housing -- homeless people would have significant challenges in terms of maternal morbidity and mortality. It has to do with transportation, especially in rural areas. We have maternal care deserts now where there are many, many hospitals that are not delivering babies, and so people have to travel large distances in particularly rural areas to get that maternal care that is needed. Healthcare access, of course, economic opportunity, education, the environment -- all of this directly relates to maternal morbidity and mortality. And we're looking at this across the board in all of our different divisions.

Faust: When you go around in your role as the leader of so many things in HHS, you talk to groups like ACOG and you talk to other groups, what are they telling you about what they're seeing on the ground with respect to the disparities that were existing before the pandemic and coming out of it? What's top of mind when you meet with an ACOG representative? That's the American College of Obstetricians and Gynecologists.

Levine: Well, there are several different issues. We actually just met with a number of different stakeholders, including ACOG, about congenital syphilis and the issues that we were talking about.

In addition, I was recently at Parkland Hospital in Dallas meeting with the obstetricians/gynecologists there, particularly about maternal morbidity and mortality. We talked a lot about syphilis. We also talked a lot about substance use during pregnancy, particularly opioids and other substances in pregnancy.

They have a great program at Parkland in terms of dealing with the stigma associated with substance use -- particularly opioid use -- and getting those people into treatment, appropriate care for the newborn after delivery, and then continuing treatment, particularly with medication-assisted treatment, after delivery. So, that's another issue that we talk with ACOG a lot about.

Another issue, though, that I want to emphasize in terms of reproductive healthcare, is in terms of the impacts of the Dobbs decision. We are seeing significant challenges in terms of reproductive healthcare access for women in those states that have banned abortion.

In addition to just the challenges with an abortion ban are the impacts upon what should be routine ob/gyn care, for example, taking care of a woman with an ectopic pregnancy, taking care of a woman with a septic miscarriage. In states that have strict abortion bans, those women are at medical risk and often have to travel to other states in order to get their care. We have created essentially medical refugees in the United States that cannot get basic healthcare in many states in our country and have to travel to other states.

I've been with the secretary, for example, in Minnesota in Minneapolis, and then we traveled to Wisconsin in Milwaukee and talked about a tale of two cities. We did the same thing in Missouri and in Illinois -- contiguous states that have different disparities in reproductive healthcare for women because of the impacts of the Dobbs decision and the actions and laws that those states have taken.

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