A shortage of penicillin to treat a skyrocketing number of syphilis cases is so dire that U.S. health officials are debating the need to declare a public health emergency, according to people familiar with the matter.

Major U.S. medical centers are rationing the recommended treatment for the deadly sexually transmitted disease because of a supply crunch. From Michigan to Missouri to Texas, some health-care providers are prioritizing giving a key treatment — penicillin G benzathine — to pregnant patients and babies, because the drug can pass through the placenta and also treat the fetus.

Syphilis has been sickening more people over the last few years, but the latest surge in cases has been especially worrying to the federal government. The Department of Health and Human Services is mobilizing a new federal task force to tackle the problem, and staff are discussing the possibility of declaring a public health emergency which could give officials access to more funding to address the crisis, according to people familiar with the matter.

“This is a remarkable shortage,” said Joseph Cherabie, an assistant professor at Washington University in St. Louis’s medical school, who treats syphilis patients. Because of the need to conserve the drug for pregnant patients, other people are getting less-than-ideal treatments for the infection.

The government’s efforts are being led by Assistant Secretary for Health Admiral Rachel Levine, according to one of the people, who asked not to be identified discussing private information. Levine has spent months recruiting experts to tackle the syphilis crisis, including officials at HHS, the Centers for Disease Control and Prevention and the Food and Drug Administration, which has been brought in to address ongoing drug shortages.

Levine and U.S. health officials at the CDC are weighing the benefits of the public health emergency declaration, such as the additional flexibility and money it would give HHS, one of the people said. They’re also considering the potential drawbacks. Some are wary a pandemic-fatigued public may consider it an overreaction and ignore similar declarations in the future. Ultimately, HHS Secretary Xavier Becerra has the power to make a declaration.

“The Department is closely monitoring the alarming rise in cases of syphilis and will continue working to address this public health threat,” an HHS spokesperson said.
Cascading Shortages

Drug shortages, though not uncommon, have hit 9-year highs in the U.S. Over the past year there have been shortages of antibiotics, chemotherapies and ADHD medicines, to name a few.
The situation is partly a result of under-investment in manufacturing after years of falling generic drug prices.

Companies have also been caught off guard by unexpected changes in demand, creating far-reaching consequences that imperil lives.

The penicillin shortage began in April. The FDA said it was caused by increases in cases of both syphilis and strep throat. Because a common antibiotic used to treat strep was in short supply this winter, patients were prescribed penicillin as an alternative, driving up demand for the drug.

That created an acute problem at a time when syphilis cases were rising precipitously. Rates of syphilis in 2021 were the highest since 1990, according to the most updated government data. In 2021, at least 176,000 cases of syphilis were reported, 32% more than the year before. The infection disproportionately impacts gay and bisexual men.

Pfizer Inc. is the only company that makes penicillin G benzathine for the U.S., selling it under the brand name Bicillin L-A.

The company has told the FDA that supply disruptions for the two most common doses of penicillin G benzathine will likely continue into the second quarter of 2024. Pfizer has added night and weekend shifts to increase production. To free up manufacturing resources, it’s also deprioritized production of a smaller dose of Bicillin L-A that’s not widely used.

Harming Babies

Syphilis is especially dangerous for pregnant people, who can pass it on to a fetus, which often results in pregnancy loss, death of a baby shortly after birth or severe disability in children. Cases of this type of syphilis, called congenital syphilis, are also at their highest rates since the 1990s. In 2021, there were 2,855 cases reported, up 32% from the year prior. The disease is completely preventable with penicillin G benzathine.

Penicillin G benzathine is also often the most recommended treatment for people who aren’t pregnant. Yet with supplies running short, the CDC is advising that doctors turn to another antibiotic, doxycycline. That’s less convenient for patients, because doxycycline is a pill given twice a day for at least two weeks, whereas penicillin G benzathine is an injection that can sometimes clear the disease completely with one dose.

That makes doctors worry that some patients might not complete their treatment with doxycycline. Syphilis particularly affects people suffering from substance abuse, housing instability or homelessness, which makes it more difficult to sustain long-term medical care.

There’s also less evidence backing the drug than there is for penicillin, according to physicians.

“We’re learning in real time how effective doxycycline can be,” Cherabie said.
Some states or health systems are directing doctors to use doxycycline for syphilis. The Michigan Department of Health and Human Services has instructed state-funded clinics to use doxycycline for certain patients because of the shortage, spokesperson Chelsea Wuth said.

At Houston Methodist, a health system with seven hospitals in the Houston area, penicillin G benzathine is reserved for pregnant patients and babies with syphilis, spokesperson Gale Smith said.
Some clinics have been able to get sufficient amounts of the Pfizer drug, at least for the time being. State-operated health clinics in South Carolina have been able to purchase as much as they need, a spokesperson for the health and environment department said.

Rise of STDs

While rates of HIV have been declining, other sexually transmitted diseases have become more prevalent in recent years. Condom use has fallen as more effective medications for HIV have become available, leaving people vulnerable to illnesses like syphilis, chlamydia and gonorrhea.

There are also fewer resources to identify people who need treatment and get them help. STD prevention work happens largely at local and state public-health departments, which have been losing money and staff over the years. The Covid-19 pandemic diverted already scarce public health resources away from STD work.

The rise in syphilis cases is prompting concern at a state level. Last year, New Mexico renewed a statewide public health order mandating that health-care providers screen pregnant women for syphilis multiple times to catch the disease. The state had only one case of congenital syphilis reported in 2017. It had 42 in 2020.