A new shortage of a type of penicillin important in the fight against syphilis is alarming infectious disease experts, who warn that a prolonged scarcity of the drug could exacerbate an epidemic of sexually transmitted infections in the United States.
The shortage announced by the drug company Pfizer in message For the past month he has been taking Bicillin LA, a long-acting injectable antibiotic also known as penicillin G benzathine. The company cited large increases in demand due to the high incidence of syphilis, as well as the recent use of Bicillin as a replacement for amoxicillin, another antibiotic that is rarely used periodically and prescribed for general infections such as strep throat.
It will likely take about a year for the company to ramp up production by 50 percent at its Rochester, Michigan, plant, and eventually manufacture enough bisillin to meet demand and shore up reserves, said Stephen Dannehy, a Pfizer spokesman.
It was syphilis On the rise in the United States since 2000to 176,713 cases in 2021, up nearly 75 percent since 2017, according to the Centers for Disease Control and Prevention.
Congenital syphilis tripled over the four-year period, to 2,855 cases, including 220 deaths or infant deaths. higher rates Among Native American children, Native Hawaiian mothers, Pacific Islanders, and Black mothers.
Bicillin is the only treatment recommended for infected pregnant women, and it is highly effective in preventing transmission of the infection to the fetus if provided early enough. Congenital syphilis It has a high mortality rate, and could otherwise cause premature birth and severe birth defects.
“It worries me that these mothers may not have access to life-saving medications,” said Dr. Anita Henderson, a pediatrician in Hattiesburg, Missouri. She said the state has seen significant increases in the incidence of congenital syphilis over the past five years.
Of the adults infected with syphilis, nearly a quarter are in women; just under a third in men who have sex with men only; And about a fifth of men who have sex only with women.
infection It can cause blisters The rash, if left untreated, can seriously damage the internal organs, nervous system, eyes and ears, and can be fatal.
Pfizer also warned that its supply of A The rarely used pediatric version of Bicillin is sold out because the company has begun using the product line of this drug to increase the adult formulation. Doctors turned to it last year in place of amoxicillin during an increase in cases of sore throats.
Beesline is also used For the management of rheumatic heart disease and Rheumatic fever, which is a particular, although uncommon, health risk for children. Multiple antibiotic alternatives are available for these conditions, according to Dr. Meg Doherty, director of global HIV, hepatitis and sexually transmitted diseases programs at the World Health Organization.
To ward off bacterial infections, military recruits receive bicillin during boot camp, where the drug is known as the “peanut butter potion” because of its color and consistency. According to Dr. Ryan C. Meaves, professor of infectious diseases at Wake Forest University School of Medicine, recruits run a high risk of infection with invasive streptococcus.
Alternatives to bicillin for pregnant women are under development and review, but they are still years away from being 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 production.
The shortage of BICILLIN is just one component of a widespread drug shortage that has left doctors and pharmacists scrambling to obtain essential therapeutic items and forcing them to ration treatments such as chemotherapy. Modern Senate a report Supply problems have also been described as a threat to national security.
Most drug companies haven’t been particularly keen on developing antibiotics, in part because the profit margin for this class of drug is much lower than the next blockbuster drug that could be worth billions of dollars.
a Bipartisan group in Congress It recently reintroduced $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.
The rates of syphilis, chlamydia and gonorrhea, said David Harvey, executive director of the National Alliance of STD Managers, a trade association of public health associations. It’s all escalating “This is partly due to a public health environment that is seriously under stress, resulting in a lack of STD prevention, testing, and treatment.”
He and others have criticized Pfizer for insufficient drug production given the decades-long upward trajectory of syphilis infections. But a Pfizer spokesman, Mr. Danehy, said the company invested $38 million in its Michigan plant to improve manufacturing after the previous Bicillin shortage in 2017.
Mr. Harvey also denounced the Biden administration for agreeing in the debt-ceiling deal to cut $400 million from the Centers for Disease Control and Prevention’s budget for STD prevention.
To extend the supply of bicillin, CDC recommend That doctors give preference to pregnant patients and infected or exposed children. 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 these individuals, including partners of pregnant women, may have difficulty adhering to the twice-daily pill regimen, which could jeopardize its effectiveness.
Eric Tichy, chief of supply chain management at the Mayo Clinic in Rochester, Minnesota, said Pfizer will likely stand alone in producing bicillin for the US market because of the sheer complexity and cost of manufacturing the drug.
But other experts took issue with Pfizer’s pricing practices. “This is a prime example of why public health leaving the free market can be disastrous,” Tim Horn, director of drug access for the National Alliance of State and Territory AIDS Managers, an advocacy group, said in an email.
“Since 2013, the price of Bicillin LA has increased by a staggering 275 percent,” said Mr. Horn.
Mr. Danehy said the list price for a 4-milliliter syringe of Bicillin LA is $470, and that the company has adjusted prices to ensure an appropriate, quality supply.
While many health care organizations and clinics are able to get discounts, some independent clinics on the front lines pay the highest price for an antibiotic.
The cost of 10 doses of Bicillin has risen to $6,500 from $4,000 two years ago, said Dr. Phyllis Ritchie, who runs a free STD clinic catering largely to gay men in Palm Springs, California. With the clinic using about 15 to 20 ten-packs a year, she said, her $225,000 annual budget could no longer withstand the financial strain.
When I first started practicing medicine in the mid-1990s, Dr. Ritchie remembered, 10-pack Cost less than $300.
“It’s a crisis,” she said.