A new shortage of a type of penicillin vital to the fight against syphilis is worrying infectious disease experts, who have warned that a prolonged shortage of the drug could worsen the US epidemic of the sexually transmitted infection.
Shortage, announced by drug maker Pfizer in a letter Last month, Bicillin LA is included, a long-acting injectable antibiotic also known as penicillin G benzathine. The company cited a significant increase in demand due to rising rates of syphilis infections, as well as the recent use of bicillin as a substitute for amoxicillin, another antibiotic that has been rare for a period of time and has been shown to be effective against more common infections such as strep throat. is determined for.
Pfizer spokesman Steven Dennehy said it would take about a year for the company to ramp up production at its plant in Rochester, Michigan, by 50 percent and eventually manufacture enough Bicillin to meet demand and increase stockpiles.
got syphilis has been on the rise in the United States since 2000According to the Centers for Disease Control and Prevention, cases are expected to reach 176,713 in 2021, an increase of nearly 75 percent since 2017.
Congenital syphilis tripled to 2,855 cases during that four-year period, including 220 stillbirths or infant deaths. rates are highest among infants of Native American, Native Hawaiian, Pacific Islander, and Black mothers.
Bicillin is the only recommended treatment for infected pregnant women, and if given early is very effective in preventing transmission to the fetus. congenital syphilis It has a high mortality rate, and otherwise it can cause premature birth and severe birth defects.
“It concerns me that these moms may not have access to life-saving drugs,” said Dr. Anita Henderson, a pediatrician in Hattiesburg, Miss. He said, the state has seen a huge increase in the rate of congenital syphilis in the last five years.
Of syphilis cases in adults, about one-quarter are in women; Less than a third are men who only have sex with men; And about a fifth are men who only have sex with women.
Infection can cause wounds And a 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 A rarely used pediatric version of Bicillin will soon be phased out as the company begins using that drug’s production line to enhance the adult formula. Doctors turned to it in place of amoxicillin during a surge in the number of strep throat cases last year.
is bicillin also used to manage rheumatic heart disease and flatulence, which although uncommon for children, are a special health risk. There are several antibiotic options available for these conditions, according to Dr. Meg Doherty, director of global HIV, hepatitis and sexually transmitted infection programs at the World Health Organization.
To avoid bacterial infection, military recruits are given bicillin during boot camp, where the drug is known as the “peanut butter shot” because of its color and consistency. Those admitted face a high risk of an otherwise invasive streptococcal infection, according to Dr. Ryan C. Mawes, professor of infectious diseases at Wake Forest University School of Medicine.
Alternatives to bicillin for pregnant women are under development and review, but are several years away from being available to them, said Dr. Jeffrey Klausner, an infectious disease specialist at the University of Southern California. He urged the Biden administration to pay Pfizer for about 500,000 doses to encourage production.
The bicillin shortage is one element of a wider drug-shortage crisis that has left doctors and pharmacists scrambling for the vital therapeutic staple and forced them to limit treatments such as chemotherapy. a recent senate reports Supply problems were also cited as a threat to national security.
Most pharmaceutical companies have not been particularly keen on developing antibiotics, as profit margins for this class of drugs are generally much smaller than the next blockbuster drug, which can cost billions of dollars.
A Bipartisan Groups in Congress $6 billion recently reintroduced pasteur actA Netflix-like subscription model that would act as a financial incentive for research and development by pharmaceutical companies. While the legislation may 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 trade association for public health associations, said rates of syphilis, chlamydia and gonorrhea all rising “In part because of a public health landscape that is dangerously thin, resulting from a lack of STI prevention, testing, and treatment.”
He and others criticized Pfizer for insufficient production of the drug, given the rising trajectory of syphilis infections over the decades. But Mr. Dennehy, a Pfizer spokesman, said the company had invested $38 million in its Michigan plant in 2017 to improve manufacturing after a previous shortage of Bicillin.
Mr. Harvey also criticized the Biden administration for agreeing to a debt ceiling agreement to cut $400 million from the CDC’s budget for STI prevention.
To increase Bicillin supplies, the C.D.C. recommended Doctors give priority to pregnant patients and infants infected or exposed. Other patients should instead be prescribed doxycycline for two to four weeks depending on the stage of the disease. But experts expressed concern that such individuals, including partners of pregnant women, may find it difficult to take the pill twice a day, compromising its effectiveness.
Eric Tichy, division chairman for supply chain management at the Mayo Clinic in Rochester, Minn., said Pfizer stands alone in producing Bicillin for the US market because of the considerable complexity and expense of manufacturing the drug.
But other experts objected to Pfizer’s pricing practices. “Here’s a prime 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,” Mr. Horn said.
Mr. Dennehy said the list price for a 4-milliliter Bicillin LA syringe is $470, and the company has adjusted prices to ensure an appropriate, quality supply.
While many health care organizations and clinics are able to obtain discounts, some leading independent clinics are paying top dollar for the antibiotic.
Dr. Phyllis Ritchie, who runs a free STI clinic serving gay men in Palm Springs, California, said the cost of a 10-pack of Bicillin shots has risen from $4,000 two years ago to $6,500. The clinic uses about 15 to 20 of the 10-packs annually, he said, adding that its $225,000 annual budget can no longer withstand the financial strain.
When He First Started Practicing Medicine In The Mid-1990s, Dr. Ritchie Remembers, 10-Pack cost less than $300,
“It’s a crisis,” he said.