Antibiotic shortages could worsen the syphilis epidemic

In an undated image from the National Institute of Allergy and Infectious Diseases, treponema pallidum, the bacterium that causes syphilis.  (NIAID via The New York Times)

In an undated image from the National Institute of Allergy and Infectious Diseases, treponema pallidum, the bacterium that causes syphilis. (NIAID via The New York Times)

A new shortage of a type of penicillin crucial for fighting syphilis is alarming infectious disease experts, who warn that a prolonged shortage of the drug could worsen the US STD epidemic.

The shortage, announced by pharmaceutical company Pfizer in a letter last month, concerns bicillin LA, a long-acting injectable antibiotic also known as penicillin G benzathine. The company cited a significant increase in demand due to the increased rate of syphilis infections, as well as the recent use of bicillin as an alternative to amoxicillin, another antibiotic that has been in periodic shortages and is prescribed for more general infections such as the strep.

Steven Danehy, a spokesman for Pfizer, said it would likely be about a year before the company ramped up production by 50% at its Rochester, Michigan plant and eventually produced enough bicillin to meet demand and shore up supplies.

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Syphilis has been on the rise in the United States since 2000, reaching 176,713 cases in 2021, an increase of nearly 75% since 2017, according to the Centers for Disease Control and Prevention.

Congenital syphilis tripled during that four-year period, to 2,855 cases, including 220 stillbirths or infant deaths. Rates are highest among children born to Native American, Native Hawaiian, Pacific Islander, and Black mothers.

Bicillin is the only recommended treatment for pregnant women who are infected and is very effective in preventing transmission to the fetus if given early enough. Congenital syphilis has a high mortality rate and can otherwise cause preterm birth and serious birth defects.

It worries me that these moms may not have access to life-saving medications, said Dr. Anita Henderson, a pediatrician in Hattiesburg, Mississippi. The state has seen large increases in the congenital syphilis rate over the past five years, she said.

Of syphilis cases in adults, nearly a quarter are in women; just under a third are men who only have sex with men; and about a fifth are men who only have sex with women.

The infection can cause sores and rashes and, if left untreated, can seriously damage internal organs, the nervous system, eyes and ears and can be fatal.

Pfizer also warned that its supply of a rarely used pediatric version of Bicillin would soon run out because the company had begun using that drug manufacturing line to augment adult formula. Doctors have turned to it over the past year in place of amoxicillin during a surge in the number of sore throat cases.

Bicillin is also used to manage rheumatic heart disease and rheumatic fever, which pose particular, though uncommon, health risks for children. Multiple antibiotic alternatives are available for these conditions, according to Dr. Meg Doherty, director of global HIV, hepatitis and STIs programs at the World Health Organization.

To ward off bacterial infections, military recruits are given bicillin during boot camp, where the drug is known as fired peanut butter due to its color and texture. According to Dr. Ryan C. Maves, professor of infectious diseases at Wake Forest University School of Medicine, recruits otherwise face a high risk of invasive strep infection.

Alternatives to bicillin for pregnant women are being developed and reviewed, but they are years away from becoming available to them, said Dr. Jeffrey Klausner, an infectious disease expert at the University of Southern California. He urged the Biden administration to pay Pfizer about 500,000 doses to encourage manufacturing.

The bicillin shortage is but one element of a widespread drug shortage crisis that has left doctors and pharmacists scrambling for vital therapeutic staples and forced them to ration treatments such as chemotherapy. Even a recent Senate report called supply problems a threat to national security.

Most pharmaceutical companies haven’t been particularly keen on developing antibiotics, in part because the profit margin for this class of drugs is typically much smaller than the next blockbuster drug that could be worth billions of dollars.

A bipartisan group in Congress recently reintroduced the $6 billion Pasteur Act, a Netflix-like subscription model that would act as a financial incentive for drug companies to research and develop. While the legislation may address drug shortages, its primary goal is to combat the global threat of drug-resistant pathogens.

David Harvey, executive director of the National Coalition of STD Directors, a trade association for public health associations, said rates of syphilis, chlamydia and gonorrhea were rising in part because of a public health landscape that is dangerously reduced, resulting in a lack of STI prevention, testing, and treatment.

He and others have criticized Pfizer for inadequately manufacturing the drug, given the decade-long escalating trajectory of syphilis infections. But Pfizer spokesman Danehy said the company has invested $38 million in its Michigan plant to improve production after an earlier bicillin shortage in 2017.

Harvey also denounced the Biden administration for agreeing to the debt ceiling deal to cut $400 million from the CDC’s STI prevention budget.

To lengthen the supply of bicillin, the CDC recommends physicians give preference to infected or exposed pregnant patients and infants. Other patients should instead be prescribed doxycycline for two to four weeks, depending on the stage of the disease. But experts have expressed concern that such individuals, including partners of pregnant women, may find it difficult to stick to the twice-daily pill regimen, potentially compromising its effectiveness.

Eric Tichy, president of the supply chain management division at the Mayo Clinic in Rochester, Minnesota, said Pfizer is likely unique in producing bicillin for the U.S. market due to the drug’s significant complexity and cost of manufacturing.

But other experts have objected to Pfizer’s pricing practices. Here’s a prime example of why leaving public health to the free market can be disastrous, said Tim Horn, director of access to medicines at the National Alliance of State and Territorial AIDS Directors, an advocacy group .

Since 2013, the price of Bicillin LA has increased an astonishing 275%, Horn said.

Danehy said the list price for a 4-milliliter Bicillin LA syringe is $470, and that the company has adjusted prices to ensure an adequate, quality supply.

While many healthcare organizations and clinics are able to get discounts, some front-line independent clinics are paying top dollar for the antibiotic.

Dr. Phyllis Ritchie, who runs a free STD clinic that serves mainly gay men in Palm Springs, California, said the cost of a 10-dose packet of bicillin had risen to $6,500 from $4,000 two years ago. does. With the clinic using about 15 to 20 of the 10-packs a year, its $225,000 annual budget can no longer handle the financial strain, she said.

When he first started practicing medicine in the mid-1990s, Ritchie recalled, a 10-pack cost less than $300.

It’s a crisis, he said.

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