A Syphilis Emergency Is Developing Due to Insufficient Penicillin G Benzathine Supply
Rates of syphilis across America exploded 32% in 2021, over 2020, to the highest level since 1990. The preferred treatment, penicillin G benzathine, is consequently in very short supply. Pfizer Inc. has told the FDA that supply disruptions for the two most common dosages of penicillin G benzathine will likely continue into the second quarter of 2024:
Syphilis Emergency Looms in the U.S. as Drugs Run Low
July 26, 2023
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.
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.
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.
Syphilis cases in US newborns rise 10-fold over a decade
By Sriparna Roy - November 8, 2023
The number of newborns with syphilis in the United States surged more than 10-fold in the last decade, the U.S. Centers for Disease Control and Prevention (CDC) reported on Tuesday.
The agency said 3,761 cases were recorded in 2022, the highest in over 30 years, up from 334 cases in 2012. The 2022 cases included 231 stillbirths and 51 infant deaths.
Nine out of 10 cases might have been prevented with timely testing and treatment during pregnancy, said Laura Bachmann, chief medical officer in CDC's Division of STD Prevention.
Syphilis is a sexually transmitted infection that can cause serious health problems without treatment, and during pregnancy, can lead to stillbirth, miscarriage, infant death, and maternal and infant morbidity.
By treating patients quickly, healthcare professionals could reduce some of the greatest hurdles to the care some mothers need, said Bachmann.
Congenital syphilis occurs when a mother with syphilis passes the infection to her baby during pregnancy.
The CDC recommends screening for syphilis at the first prenatal care visit to reduce perinatal transmission.
Benzathine penicillin G is the only recommended treatment for syphilis during pregnancy that must be administered as a single-dose injection or three doses spaced seven to nine days apart, depending on the stage of infection, according to the CDC.
Everything you never wanted to know about syphilis, but now need to.
If nothing else, Wiki wins on sheer number of citations, which I've clipped here.
Syphilis (/ˈsɪfəlɪs/) is a sexually transmitted infection caused by the bacterium Treponema pallidum subspecies pallidum. The signs and symptoms of syphilis vary depending in which of the four stages it presents (primary, secondary, latent, and tertiary). The primary stage classically presents with a single chancre (a firm, painless, non-itchy skin ulceration usually between 1 cm and 2 cm in diameter) though there may be multiple sores. In secondary syphilis, a diffuse rash occurs, which frequently involves the palms of the hands and soles of the feet. There may also be sores in the mouth or vagina. In latent syphilis, which can last for years, there are few or no symptoms. In tertiary syphilis, there are gummas (soft, non-cancerous growths), neurological problems, or heart symptoms. Syphilis has been known as "the great imitator" as it may cause symptoms similar to many other diseases.
After decreasing dramatically with the availability of penicillin in the 1940s, rates of infection have increased since the turn of the millennium in many countries, often in combination with human immunodeficiency virus (HIV). This is believed to be partly due to increased sexual activity, increased prostitution, and decreased use of condoms.
It's an ancient disease, difficult because it varies so much in the way it shows up.
Historically, straight talk about syphilis wasn't politically correct. But wow, those Renaissance artists didn't let that stop them.
The first recorded outbreak of syphilis in Europe occurred in 1494/1495 in Naples, Italy, during a French invasion. Because it was spread by returning French troops, the disease was known as "French disease", and it was not until 1530 that the term "syphilis" was first applied by the Italian physician and poet Girolamo Fracastoro. The causative organism, Treponema pallidum, was first identified by Fritz Schaudinn and Erich Hoffmann in 1905 at the Charité Clinic in Berlin. The first effective treatment, Salvarsan, was developed in 1910 by Sahachiro Hata in the laboratory of Paul Ehrlich. It was followed by the introduction of penicillin in 1943.
Many well-known figures, including Scott Joplin, Franz Schubert, Friedrich Nietzsche, Al Capone, and Édouard Manet are believed to have contracted the disease.
The history of syphilis has been well studied, but the exact origin of the disease remains unknown. There are two primary hypotheses: one proposes that syphilis was carried to Europe from the Americas by the crew(s) of Christopher Columbus as a byproduct of the Columbian exchange, while the other proposes that syphilis previously existed in Europe but went unrecognized. There has been a recent skeletal discovery in the Yucatan Peninsula dating over 9,900 years ago of a 30 year old woman who had Treponema peritonitis, a disease related to syphilis. "There is also evidence for a possible trepanomal bacterial disease that caused severe alteration of the posterior parietal and occipital bones of the cranium." Syphilis was the first "new" disease to be discovered after the invention of printing....
Health offices warn of shortage of syphilis drug as cases riseIn a survey from the National Coalition of STD Directors conducted in early November, 46% of sexual health clinics said they'd tried to order Bicillin L-A -- only to find that it was unavailable. Photo by Thirdman/Pexels
As syphilis cases surge across America, a group representing the nation's STD specialists says members are reporting shortages of a drug essential to fighting the disease.
In a survey from the National Coalition of STD Directors conducted in early November, 46% of sexual health clinics said they'd tried to order Bicillin L-A -- only to find that it was unavailable.
Bicillin L-A, a form of penicillin, is crucial to the treatment of syphilis. That's especially true for congenital syphilis, which occurs when a newborn contracts the illness from an infected mother.
Early in November, the U.S. Centers for Disease Control and Prevention sounded the alarm on the disease, noting that rates of congenital syphilis soared 10-fold between 2012 and 2022.
In 2022, more than 3,700 babies across the United States were born with syphilis, the CDC said.
According to the March of Dimes, "If not treated right away, congenital syphilis can cause problems for your baby later in life," including deformities of the bones and teeth, paralysis or seizures, problems with vision and hearing and developmental delays.
Luckily, Bicillin L-A can quickly vanquish the syphilis bacterium. It's the only treatment approved for pregnant women with syphilis, and it's also the first-line therapy for syphilis patients generally.
The new survey confirms that Bicillin L-A is in short supply nationwide.
The group sent its survey to 136 state and local health departments and 151 sexual health clinics in early November.
Among the findings:
- Respondents in 13 different states and one Indian Health Services agency said they'd received reports of at least one pregnant woman who'd been unable to receive Bicillin L-A
- Nearly half (46%) of clinics said they'd had difficulties getting Bicillin L-A, a increase from the 40% of clinics who hadn't been able to access the drug when a prior survey was conducted in August
- More than two-thirds (68%) of health department specialists believe shortages will cause syphilis cases to rise even higher in their jurisdictions
There is a second-line treatment, doxycycline, which patients can use if Bicillin L-A is not available. But treatment can take a month and severe side effects can occur.
In the new survey, 36% of clinics said they'd had a patient who could not complete their full course of doxycycline.
The CDC has already advised that, to preserve supply, doctors use Bicillin L-A only for cases of congenital syphilis and give doxycycline to all other patients.
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