Syphilis Is Killing Babies. The U.S. Government Is Failing to Stop the Disease From Spreading. — ProPublica

Karmin Strohfus, the lead nurse at a South Dakota jail, punched numbers into a phone like lives depended on it. She had in her care a pregnant woman with syphilis, a highly contagious, potentially fatal infection that can pass into the womb. A treatment could cure the woman and protect her fetus, but she couldn’t find it in stock at any pharmacy she called — not in Hughes County, not even anywhere within an hour’s drive.

Most people held at the jail where Strohfus works are released within a few days. “What happens if she gets out before I’m able to treat her?” she worried. Exasperated, Strohfus reached out to the state health department, which came through with one dose. The treatment required three. Officials told Strohfus to contact the federal Centers for Disease Control and Prevention for help, she said. The risks of harm to a developing baby from syphilis are so high that experts urge not to delay treatment, even by a day.

Nearly three weeks passed from when Strohfus started calling pharmacies to when she had the full treatment in hand, she said, and it barely arrived in time. The woman was released just days after she got her last shot.

Last June, Pfizer, the lone U.S. manufacturer of the injections, notified the Food and Drug Administration of an “impending stock out” that it anticipated would last a year. The company blamed “an increase in syphilis infection rates as well as competitive shortages.”

Across the country, physicians, clinic staff and public health experts say that the shortage is preventing them from reining in a surge of syphilis and that the federal government is downplaying the crisis. State and local public health authorities, which by law are responsible for controlling the spread of infectious diseases, report delays getting medicine to pregnant people with syphilis. This emergency was predictable: There have been shortages of this drug in eight of the last 20 years.

Yet federal health authorities have not prevented the drug shortages in the past and aren’t doing much to prevent them in the future.

Syphilis, which is typically spread during sex, can be devastating if it goes untreated in pregnancy: About 40% of babies born to women with untreated syphilis can be stillborn or die as newborns, according to the CDC. Infants that survive can suffer from deformed bones, excruciating pain or brain damage, and some struggle to hear, see or breathe. Since this is entirely preventable, a baby born with syphilis is a shameful sign of a failing public health system.

In 2022, the most recent year for which the CDC has data available, more than 3,700 babies were infected with syphilis, including nearly 300 who were stillborn or died as infants. More than 50% of these cases occurred because, even though the pregnant parent was diagnosed with syphilis, they were never properly treated.

That year, there were 200,000 cases identified in the U.S., a 79% increase from five years before. Infection rates among pregnant people and babies increased by more than 250% in that time; South Dakota, where Strohfus works, had the highest rates — including a more than 400% increase among pregnant women. Statewide, the rate of babies born with the disease, a condition known as congenital syphilis, jumped more than 40-fold in just five years.

And that was before the current shortage of shots.

In Mississippi, the state with the second highest rate of syphilis in pregnant women, Dr. Caroline Weinberg started having trouble this summer finding treatments for her clinic’s patients, most of whom are uninsured, live in poverty or lack transportation. She began spending hours each month scouring medicine suppliers’ websites for available doses of the shots, a form of penicillin sold under the brand name Bicillin L-A.

“The way people do it for Taylor Swift, that’s how I’ve been with the Bicillin shortage,” Weinberg said. “Desperately checking the websites to see what I can snag.”

The shortage is driving up infection rates even further.

The way people do it for Taylor Swift, that’s how I’ve been with the Bicillin shortage. Desperately checking the websites to see what I can snag.

In a November survey by the National Coalition of STD Directors, 68% of health departments that responded said the drug shortage will cause syphilis rates in their area to increase, further crushing the nation’s most disadvantaged populations.

“This is the most basic medicine,” said Meghan O’Connell, chief public health officer for the Great Plains Tribal Leaders’ Health Board, which represents 18 tribal communities in South Dakota and three other states. “We allow ourselves to continue to not have enough, and it impacts so many people.”

ProPublica examined what the federal government has done to manage the crisis and the ways in which experts say it has fallen short.

The government could pressure Pfizer to be more transparent.

Twenty years ago, there were at least three manufacturers of the syphilis shot. Then Pfizer, one of the manufacturers, purchased the other two companies and became the lone U.S. supplier.

Pfizer’s supply has fallen short since then. In 2016, the company announced a shortage due to a manufacturing issue; it lasted two years. Even during times when Pfizer had not notified the FDA of an official shortage, clinics across the country told ProPublica, the shots were often hard to get.

Several health officials said they would like to see the government use its power as the largest purchaser of the drug to put pressure on Pfizer to produce adequate supplies and to be more transparent about how much of the drug they have on hand, when it will be widely available and how stable the supply will be going forward.

In response to questions, Pfizer said there are two reasons its supply is falling short. One, the company said, was a surge in use of the pediatric form of the drug after a shortage of a different antibiotic last winter. Pfizer also blamed a 70% increase in demand for the adult shots since last February, which it described as unexpected.

Public health experts say the increase in cases and subsequent rise in demand was easy to see coming. Officials have been raising the alarm about skyrocketing syphilis cases for years. “If Pfizer was truly caught completely off guard, it raises significant questions about the competency of the company to forecast obvious infectious disease trends,” a coalition of organizations wrote to the White House Drug Shortage Task Force in September.

Pfizer said it is consistently communicating with the CDC and FDA about its supply and that it has been transparent with public health groups and policymakers.

The FDA has a group dedicated to addressing drug shortages. But Valerie Jensen, associate director of that staff, said the FDA can’t force manufacturers to make more of a drug. “It is up to manufacturers to decide how to respond to that increased demand.” she said. “What we’re here to do is help with those plans.”

Pfizer said it had a target of increasing production by about 20% in 2023 but faced delays toward the end of the year. The company did not explain the reason for those delays.

The company said it has invested $38 million in the last five years in the Michigan facility where it makes the shots and that it is increasing production capacity. It also said it is adding evening shifts at the facility and actively recruiting and training new workers. Pfizer said it also reduced manufacturing time from 110 to 50 days. By the end of June, the company expects the supply to recover, which it described as having eight weeks of inventory based on its forecast demands with no disruptions in sight.

The government could manufacture the drug itself.

Having only one supplier for a drug, especially one of public health importance, makes the country vulnerable to shortages. With just one manufacturer, any disruption — contamination at a plant, a shortage of raw materials, a severe weather event or a flawed prediction of demand — can put lives at risk. What’s ultimately needed, public health experts say, is another manufacturer.

Congressional Democrats recently introduced a bill that would authorize the U.S. Department of Health and Human Services to manufacture generic drugs in exactly this scenario, when there are few manufacturers and regular shortages. Called the Affordable Drug Manufacturing Act, it would also establish an office of drug manufacturing.

This same bill was introduced in 2018, but it didn’t have bipartisan support and was never taken up for a vote. Sen. Elizabeth Warren, the Massachusetts Democrat who introduced the bill in the Senate, said she’s hopeful this time will be different. Lawmakers from both parties understand the risks created by drug shortages, and COVID-19 helped everyone understand the role the government can play to boost manufacturing.

Still, it’s unlikely to be passed with the current gridlock in Congress.

The government could reserve syphilis drugs for infected patients.

Responding to the shortage of shots to treat the disease, the CDC in July asked health care providers nationwide to preserve the scarce remaining doses for people who are pregnant. The shots are considered the gold standard treatment for anyone with syphilis, faster and with fewer side effects than an alternative pill regimen. And for people who are pregnant, the pills are not an option; the shots are the only safe treatment.

Despite that call, the military is giving shots to new recruits who don’t have syphilis, to prevent outbreaks of severe bacterial respiratory infections. The Army has long administered this treatment at boot camps held at Fort Leonard Wood, Fort Moore and Fort Sill. The Army has been unable to obtain the shots several times in the past few years, according to the U.S. Army Center for Initial Military Training. But the Defense Health Agency’s pharmacy operations center has been working with Pfizer to ensure military sites can get them, a spokesperson for the Defense Health Agency said.

“Until we think about public health the way we think about our military, we’re not going to see a difference,” said Dr. John Vanchiere, chief of pediatric infectious diseases at Louisiana State University Health Shreveport.

Some public health officials, including Alaska’s chief medical officer, Dr. Anne Zink, questioned whether the military should be using scarce shots for prevention.

“We should ask if that’s the best use,” she said.

Using antibiotics to prevent streptococcal outbreaks is a well-established, evidence-based public health practice that’s also used by other branches of the armed services, said Lt. Col. Randy Ready, a public affairs officer with the Army’s Initial Military Training center. “The Army continues to work with the CDC and the entire medical community in regards to public health while also taking into account the unique missions and training environments our Soldiers face,” including basic training, Ready said in a written statement.

The government isn’t stockpiling syphilis drugs.

In rare instances, the federal government has created stockpiles of drugs considered key to public health. In 2018, confronting shortages of various drugs to treat tuberculosis, the CDC created a small stockpile of them. And the federal Administration for Strategic Preparedness and Response keeps a national stockpile of supplies necessary for public health emergencies, including vaccines, medical supplies and antidotes needed in case of a chemical warfare attack.

In November, the Biden administration announced it was creating a new syphilis task force. When asked why the federal government doesn’t stockpile syphilis treatments, Adm. Rachel Levine, the HHS official who leads the task force, said officials don’t routinely stockpile drugs, because they have expiration dates.

In a written statement, an HHS spokesperson said that Bicillin has a shelf life of two years and that the Strategic National Stockpile “does not deploy products that are commercially available.” In general, the spokesperson wrote, stockpiles are most effective before a national shortage begins and can’t overcome the problems of limited suppliers or fragile supply chains. “There is also a risk that stockpiles can exacerbate shortages, particularly when supply is already low, by removing drugs from circulation that would have otherwise been available,” the spokesperson wrote.

Stephanie Pang, a senior director with the coalition of STD directors, said that given the critical role of this drug and the severe access concerns, she thinks a stockpile is necessary. “I don’t have another solution that actually gets drugs to patients,” Pang said.

The government could declare a federal emergency.

Some public health officials say the federal government needs to treat the syphilis crisis the way it did Ebola or monkeypox.

Declare a federal emergency, said Dr. Michael Dube, an infectious disease specialist for more than 30 years. That would free up money for more public health staff and fund more creative approaches that could lead to a long-term solution to the near-constant shortages, he said. “I’d hate to have to wait for some horrible anecdotes to get out there in order to get the public’s and the policymakers’ minds on it,” said Dube, who oversees medical care for AIDS Healthcare Foundation wellness clinics across the country.

Citing an alarming surge in syphilis cases, the Great Plains Tribes wrote to the HHS secretary last week asking that the agency declare a public health emergency in their areas. In the request, they asked HHS to work globally to find adequate syphilis treatment and send the needed medicine to the Great Plains region.

During the 2014 outbreak of Ebola in West Africa, Congress gave hundreds of millions of dollars to HHS to help develop new rapid tests and vaccines. Facing a global outbreak of monkeypox in 2022, a White House task force deployed more than a million vaccines, regularly briefed the public and sent extra resources to Pride parades and other places where people at risk were gathered.

I’d hate to have to wait for some horrible anecdotes to get out there in order to get the public’s and the policymakers’ minds on it.

Levine, leader of the federal syphilis task force, countered that declaring an emergency wouldn’t make much of a difference. The government, she said, already has a “dramatic and coordinated response” involving several agencies.

The FDA recently approved an emergency import of a similar syphilis treatment made by a French manufacturer that had plenty on hand. According to the company, Provepharm, the imported shots are enough to cover approximately one or two months of typical use by all people in the U.S. (The FDA would not say how many doses Provepharm sent, and the company said it was not allowed to reveal that number under the federal rules governing such emergency imports.)

Clinics applaud that development. But many of them can’t afford the imported shots.

The government could do more to rein in the cost.

Clinics and hospitals that primarily serve low-income patients often qualify for a federal program that allows them to purchase drugs at steeply discounted prices. Pharmaceutical companies that want Medicaid to cover their outpatient drugs must participate in the program.

One factor in determining the discount price is whether a pharmaceutical company has raised the price of a drug by more than the rate of inflation. Because Pfizer has hiked the price of its Bicillin shots significantly over the years, the government requires that it be sold to qualifying clinics for just pennies a dose. Otherwise, a single Pfizer shot can retail for upwards of $500. The French shots are comparable in retail price and not eligible for the discount program.

Several clinic directors also said they worried that drug distributors were reserving the limited supply of the Pfizer shot for organizations that could pay full price. For several days in January, for example, the website of Henry Schein, a medical supplier, showed doses of the shot available at full price, while doses at the penny pricing were out of stock, according to screenshots shared with ProPublica. When asked whether it was only selling shots at full price, a spokesperson for Henry Schein did not respond to the question.

Local health departments that qualify for the discount program told ProPublica they’ve had to pay full price at other distributors, because it was the only stock available.

The Health Resources and Services Administration, the federal agency that regulates the discount program, said that a drug manufacturer is ultimately responsible for ensuring that when supplies are available, they are available at the discounted price. When asked about this, Pfizer said that it has “one inventory that is distributed to our trade partners” and that hospitals and clinics that qualify for the discount program are “responsible for ensuring compliance with the program and orders through the wholesaler accordingly.” The company added, “Pfizer plays no part in this process.”

In October, on Weinberg’s regular search for shots for her Mississippi clinic, she found doses of Bicillin for sale at the discounted price and purchased 40. “The idea that we’re supposed to be hoarding treatment is a horrific compact,” she said. Word got out that the clinic, called Plan A, has some shots, and other clinics began sending pregnant patients there.

The clinic’s supply is dwindling. Weinberg is happy to get the shots to patients who need them. But she’s not sure how much longer her reserve will last — or if she’ll be able to find more when they’re gone.