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A new shortage of a type of penicillin crucial for the fight against syphilis worries infectious disease experts, who warn that a prolonged shortage of the drug could worsen the American epidemic of sexually transmitted infections.
The shortage, announced by the pharmacist Pfizer in a letter last month involves Bicillin LA, a long-acting injectable antibiotic also known as benzathine penicillin G. The company cited significant increases in demand due to the rising rate of syphilis infections, as well as the recent use of Bicillin as an alternative to amoxicillin, another antibiotic that has periodically been in short supply and which is prescribed for more general infections like strep throat.
Steven Danehy, a spokesperson for Pfizer, said it would likely take the company about a year to increase production by 50% at its Rochester, Michigan, plant and eventually manufacture enough Bicillin to meet its demand. demand and strengthen reserves.
Syphilis has been rising in the United States since 2000reaching 176,713 cases in 2021, an increase of nearly 75% since 2017, according to the Centers for Disease Control and Prevention.
Congenital syphilis tripled over that four-year period, to 2,855 cases, including 220 stillbirths or infant deaths. The prices are the highest among infants of Native American, Hawaiian, Pacific Islander, and Black mothers.
Bicillin is the only recommended treatment for infected pregnant women 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 premature birth and serious birth defects.
“It worries me that these mothers don’t have access to lifesaving medicine,” said Dr. Anita Henderson, a pediatrician in Hattiesburg, Mississippi. The state has seen steep increases in the rate of congenital syphilis over the past five years, she said.
Among adult syphilis cases, almost a quarter are 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 rash and, if left untreated, can cause severe damage to 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 would soon be sold out because the company had started using the drug’s production line to augment the adult formula. Doctors turned to it last year instead of amoxicillin amid a surge in the number of case of strep throat.
Bicillin is also used to manage rheumatic heart disease and acute articular rhumatism, which are particular, although infrequent, risks to the health of children. According to Dr. Meg Doherty, director of the global programs on HIV, hepatitis and sexually transmitted infections at the World Health Organization, several antibiotic alternatives are available for these conditions.
To ward off bacterial infections, military recruits are given bicillin during boot camp, where the drug is known as “peanut butter shot” due to its color and consistency. 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.
Bicillin alternatives for pregnant women are being developed and tested, but they won’t be available for years, 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 bicillin shortage is just one part of a wider drug shortage crisis which left doctors and pharmacists scrambling for life-saving therapeutic staples and forced them to ration treatments like chemotherapy. A recent Senate report also referred to supply problems as 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 lower than the next blockbuster drug that could be worth billions of dollars.
A bipartisan group in Congress recently reintroduced the $6 billion Pasteur lawa Netflix genre subscription model this would act as a financial incentive for research and development by pharmaceutical companies. While the legislation could address drug shortages, its main purpose is to tackle 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 are all in full swing “in part because of a dangerously stretching public health landscape resulting in a lack of STI prevention, testing and treatment.”
He and others have criticized Pfizer for inadequately producing the drug given the rising trajectory of syphilis infections for decades. But Pfizer spokesman Mr Danehy said the company had invested $38 million in its Michigan plant to improve manufacturing after a previous Bicillin shortage in 2017.
Mr. Harvey also denounced the Biden administration for agreeing in the debt ceiling agreement to cut $400 million from the CDC’s STI prevention budget.
To stretch the Bicillin supply, the CDC recommended that physicians give priority to pregnant patients and infants who are infected or exposed. 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 people, including partners of pregnant women, may find it difficult to stick to the twice-daily pill regimen, potentially compromising its effectiveness.
Eric Tichy, director of the supply chain management division at Mayo Clinic in Rochester, Minnesota, said Pfizer is likely the only producer of Bicillin for the U.S. market due to complexity and cost. considerable amounts of drug manufacturing.
But other experts have objected to Pfizer’s pricing practices. “Here’s a great example of why leaving public health to the free market can be disastrous,” said Tim Horn, director of drug access at the National AIDS Alliance of State and Territory Directors. , an advocacy group, in an email.
“Since 2013, the price of Bicillin LA has increased by 275%,” Horn said.
Danehy said the list price for a 4-milliliter Bicillin LA syringe was $470, and the company had adjusted prices to ensure quality supply.
While many health care organizations and clinics are able to secure 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 10-pack of Bicillin shots had risen to $6,500 from $4,000 it two years ago. With the clinic using about 15 to 20 of the 10 packs a year, its $225,000 annual budget can no longer sustain the financial strain, she said.
When she began practicing medicine in the mid-1990s, Dr. Ritchie recalls, a 10-pack costs less than $300.
“It’s a crisis,” she said.
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