A shortage of antibiotics can exacerbate the syphilis epidemic

A new shortage of a type of penicillin critical to fighting syphilis is alarming to infectious disease experts, who warn that a prolonged shortage of the drug could exacerbate the U.S. epidemic of the sexually transmitted infection.

The shortage, announced by drugmaker Pfizer in a letter last month it was Bicillin LA, a long-acting injectable antibiotic also known as penicillin G benzathine. The company cited a significant increase in demand due to the rising number of syphilis infections, as well as the recent use of Bicillin as an alternative to amoxicillin, another antibiotic that is periodically in short supply and prescribed for more common infections such as strep throat.

Steven Danehy, a Pfizer spokesman, said it would likely take about a year for the company to ramp up production at its Rochester, Michigan, plant by 50 percent and eventually produce enough bicillin to meet demand and expand reserves. to reinforce.

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

Congenital syphilis tripled in that four-year period to 2,855 cases, including 220 stillbirths or infant deaths. The rates are the highest among babies 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 administered early enough. Congenital syphilis has a high mortality rate and can otherwise cause premature birth and severe birth defects.

“It worries me that these mothers may not have access to life-saving medication,” said Dr. Anita Henderson, pediatrician at Hattiesburg, Miss. The state had seen large increases in the rate of congenital syphilis over the last five years, she said.

Nearly one-fourth of adult syphilis cases 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 ulcers and skin rashes and, if left untreated, can cause severe damage to internal organs, nervous system, eyes and ears and can be fatal.

Pfizer also warned that the delivery of a the rarely used pediatric version of bicillin would soon run out as the company had turned to that drug’s production line to augment the adult formula. Doctors turned to amoxicillin instead of amoxicillin over the past year during an increase in strep throat cases.

bicillin is also used to treat rheumatic heart disease and rheumatic fever, which are particular health risks, albeit uncommon, for children. According to dr. Meg Doherty, director of global programs for HIV, hepatitis and sexually transmitted diseases at the World Health Organization, there are multiple antibiotic alternatives available for these conditions.

To ward off bacterial infections, military recruits are given bicillin during boot camp, where the drug is known as the “peanut butter shot” because of its color and consistency. Otherwise, according to Dr. Ryan C. Maves, an infectious disease professor at Wake Forest University School of Medicine, recruits are at high risk for invasive strep infection.

Alternatives to Bicillin for pregnant women are under development and evaluation, but it will be years before they become 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 some 500,000 doses to encourage production.

The shortage of bicillin is just one part of a widespread drug shortage crisis that has left doctors and pharmacists scrambling for essential basic therapeutics and forcing them to ration treatments such as chemotherapy. A recent Senate report also characterized the supply problems as a threat to national security.

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

a bipartisan group in Congress recently reintroduced the $6 billion Pasteur’s lawa Netflix-like subscription model that would serve as a financial incentive for research and development by pharmaceutical companies. While the legislation could address drug shortages, its main goal is to combat the global threat of drug-resistant pathogens.

David Harvey, executive director of the National Coalition of STD Directors, a public health association trade association, said the number of cases of syphilis, chlamydia and gonorrhea are all rising “Partly because of a public health landscape that has been stretched dangerously thin, resulting in a lack of STI prevention, testing and treatment.”

He and others criticized Pfizer for inadequate production of the drug given the decades-long rising trajectory of syphilis infections. But Pfizer spokesman Danehy said the company had invested $38 million at its Michigan plant to improve production after a previous bicillin shortage in 2017.

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

To stretch the Bicillin supply, the CDC recommends that doctors prefer pregnant patients and infected or exposed babies. Other patients should instead receive doxycycline for two to four weeks, depending on the stage of the disease. But experts were concerned that such individuals, including the partners of pregnant women, could have difficulty sticking to the twice-daily pill regimen, compromising its effectiveness.

Eric Tichy, division president of supply chain management at Mayo Clinic in Rochester, Minn., said Pfizer is likely alone in producing bicillin for the U.S. market because of the significant complexity and cost of manufacturing the drug.

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

“Since 2013, the price of Bicillin LA has increased by an astonishing 275 percent,” said Mr. Horn.

Mr Danehy said the list price for a 4-milliliter Bicillin LA syringe is $470, and the company has adjusted prices to ensure a good supply of high quality.

While many healthcare organizations and clinics can get discounts, some front-line independent clinics pay top dollar for the antibiotic.

Dr. Phyllis Ritchie, who runs a free STI clinic serving mostly gay men in Palm Springs, California, said the cost of a pack of 10 injections of Bicillin had jumped from $4,000 two years ago to $6,500. With the clinic using about 15 to 20 of the 10-packs annually, the $225,000 annual budget can no longer handle the financial strain, she said.

When she first started practicing medicine in the mid-1990s, Dr. Ritchie herself, a 10-pack costs less than $300.

“It’s a crisis,” she said.