By Eleanor Laise
Shortages of injectable penicillin made by Pfizer raise alarms as syphilis cases hit 70-year high
The U.S. Department of Health and Human Services is proposing a federal task force to lead the public-health response to a surge in syphilis cases, a department spokesperson told MarketWatch Thursday.
The task force, which has not yet been officially announced, is being formed amid growing concern about the spread of the sexually transmitted disease as supplies of a key syphilis treatment run short. State health officials and members of the Presidential Advisory Council on HIV/AIDS have warned federal health officials that the rise in cases presents an immediate threat.
The increasing number of cases have amplified concerns about the availability of an injectable penicillin, made by Pfizer (PFE) and sold under the brand name Bicillin L-A, that is the first-line recommended treatment for syphilis and the only treatment option for some patients. Pfizer warned customers in mid-June that Bicillin supplies were running low, in part due to “significant increases in demand” stemming from increasing syphilis infection rates.
The most concerning aspect of the Bicillin shortage is that “we really need that for pregnant patients with syphilis,” said Erin Fox, a drug-shortage expert at University of Utah Health. “It’s the only thing we have.”
U.S. syphilis cases hit a 70-year high in 2021, totaling more than 176,000, according to the latest data available from the Centers for Disease Control and Prevention. Syphilis can cause sores, lesions, fever and pain, and if left untreated it can damage the heart and central nervous system.
U.S. syphilis cases jumped 32% in 2021, according to the CDC. Among those cases, congenital syphilis — the disease that occurs when a mother with syphilis passes the infection to her baby during pregnancy — also rose 32% and caused more than 220 stillbirths and infant deaths, according to the CDC. Those deaths are “a stark reminder of the need to prevent the worst outcomes related to STDs,” the CDC said when releasing the data.
Some local officials have also flagged the problem. The Houston Health Department earlier this month reported a syphilis outbreak, saying there was a 128% increase in cases among women and a ninefold rise in congenital syphilis in Houston and Harris County.
Nationwide, rates of primary and secondary syphilis — the most infectious stages of the disease — have increased almost every year since falling to historic lows in 2000 and 2001, according to the CDC.
Cases have climbed amid pandemic-related disruptions in the standard prevention, screening and care that is typically focused on sexually transmitted diseases.
Pfizer said it is currently prioritizing production of Bicillin in response to the increase in syphilis infection rates. Although shortages of the drug remain, Pfizer said it does not anticipate that it will completely run out of stock. A pediatric version of Bicillin is also in shortage and may become depleted, but it is not widely used, according to Pfizer. Bicillin treatments are not produced or stored at the Pfizer facility in Rocky Mount, N.C., that was hit by a tornado last week, an event that also triggered drug-shortage concerns.
The U.S. Food and Drug Administration believes that increased demand for Bicillin stems from increased cases of strep throat as well as syphilis, an FDA official told MarketWatch. The FDA is working with Pfizer and offering assistance to help with supply, and additional releases of the adult Bicillin formulation are expected this month, the official said.
While the FDA can’t require a pharmaceutical company to make more of a drug or change its distribution, the agency “is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” the FDA said in a statement to MarketWatch.
There are treatment alternatives that may work for some syphilis patients, such as doxycycline, but they can require patients to take a pill regularly over the span of several weeks, rather than just getting a shot.
The Department of Health and Human Services in early June released a federal plan to address the growing threat of STDs. The plan aims to provide a blueprint for public-health officials, government agencies, community organizations, researchers and private industry to develop and expand programs aimed at preventing STDs and providing care to patients over the next five years.
“The Department is closely monitoring the alarming rise in syphilis cases and will continue working to address this public health threat,” an HHS spokesperson said in a statement to MarketWatch.
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