| Happy Monday, Health 202 readers! Telling people I cover sex and drugs makes for great small talk. Lately, I've noticed people really perk up when I tell them about a new Plan B pill to avoid STIs — and that's partly what led to this story. Not a subscriber? Sign up here. Today's edition: A first-in-the-nation opioid trial kicks off today in Alabama, and most of the tornado damage to a key Pfizer pharmaceutical plant appears to have missed production areas. But first … | Doxycycline is being prescribed to prevent STIs – but that could fuel antibiotic resistance |  A bottle of the antibiotic doxycycline hyclate. (Rich Pedroncelli/AP) | | | Public health officials have discovered a powerful new weapon in the war against rising sexually transmitted infections: a common antibiotic that works as a morning-after pill. For the past decade, people have been able to have unprotected sex with a low risk of contracting HIV thanks to daily pills known as PrEP, or pre-exposure prophylaxis. But they were still susceptible to bacterial bugs, including the recent spike in syphilis, gonorrhea and chlamydia — until now. Recent studies show taking the antibiotic doxycycline after sexual encounters works as a post-exposure prophylaxis to prevent those infections. But experts are also worried about unintended consequences. The Centers for Disease Control and Prevention plans to issue guidelines later this summer for deploying the treatment, known as DoxyPEP, in hopes of addressing fears among medical professionals that preventive use would fuel antibiotic resistance — and the rise of drug-resistant superbugs. | - "It's the first major intervention we've had for STIs since the vaccine for human papillomavirus," nearly two decades ago, said Jonathan Mermin, who leads STI prevention for the CDC. "But it is a new intervention, and because of that, there are potential benefits and potential risks."
| | Doctors, public health officials and sexual health clinics have embraced preventive pills as a realistic way to curb STIs because they preserve pleasure while protecting partners. Some doctors have started prescribing it to a narrow segment of the gay community considered at elevated risk for STIs. | - "Just like PrEP was a game changer, this empowers individuals to make choices about their sexual health," said Jorge Roman, senior director of clinical services at the San Francisco AIDS Foundation, one of the first to widely distribute DoxyPEP. "It doesn't always have to be about condoms."
| | | | | | | | Prescriptions are too expensive and managing your care can be complicated. We're finding ways to make it better ever step along the way. Learn how we're working to "Optumize" pharmacy care. | | | |  | | | | | Doxycycline is already used as a front-line antibiotic treatment for chlamydia and occasionally for syphilis and gonorrhea. | - The treatment was found effective in a study of 500 patients in San Francisco and Seattle. The study found a roughly 65 percent reduction in syphilis, gonorrhea and chlamydia cases in those who used DoxyPEP between 2019 and 2022, mirroring similar results from European studies.
- But another study of DoxyPEP use by cisgender women in Kenya between 2020 and 2022 did not find the treatment effective, a result that surprised and stumped researchers. Anatomical differences could play a role, but health officials say other studies suggest doxycycline becomes concentrated enough in vaginal fluid to confer protection against STIs.
| | Researchers studying DoxyPEP are scrutinizing whether it could also render antibiotic treatments less effective. The U.S. study found a slight increase in antibacterial resistance, which the study's authors said merits long-term attention. But they also said the finding should be tempered by the fact doctors would also be administering fewer antibiotics if people avoid catching and spreading STIs. David Hyun, director of the Antibiotic Resistance Project at the Pew Charitable Trusts, said he was concerned by patients in the study using DoxyPEP as frequently as 20 times a month. More data is needed to understand the long-term effects — for individuals as well as broader communities, he said. "If you keep exposing a patient to antibiotics like doxycycline, you are raising the risk of that patient being colonized or infected with a resistant strain sometime in the future," Hyun said. Proponents of DoxyPEP said it offers a long-needed solution to a spike in STIs. The CDC recorded more than 2.5 million cases of syphilis, gonorrhea and chlamydia in 2021, up from 1.8 million in 2011. In 2021, 36 percent of syphilis and gonorrhea cases were in men who have sex with men, according to the CDC. But cases in women and heterosexual men have also been rising. | | In San Francisco, the first major jurisdiction where public health officials recommended DoxyPEP, providers noticed patients taking a similar approach: Using it after higher-risk sexual encounters rather than every encounter. "We need to do more analysis to see if that could be making DoxyPEP less effective or if perhaps people are making really good decisions about when to use it," said Stephanie Cohen, who leads STI prevention for the San Francisco Department of Public Health. | | The San Francisco AIDS Foundation, which says it has connected more than 1,800 people to DoxyPEP, counsels patients on the unknown risks of antibiotic resistance. For those who have one or two partners a year, the risks of long-term antibiotic use may outweigh the benefits, Roman said. Anu Hazra, co-medical director of the Howard Brown Health, an LGBTQ+ health provider in Chicago, said antimicrobial resistance is "probably the largest public health threat we have," but doxycycline for a small group of people pales in comparison to the rampant use of antibiotics in the meat industry and other sectors. Read Fenit's full report here. | | |  | In the courts | | First opioid state trial involving hospitals begins |  The defendants are accused of fueling an opioid crisis that drove up costs for hospitals. (Mark Lennihan/AP) | | | On tap today: The first major test of whether hospitals can use state courts to hold drugmakers and distributors accountable for the opioid crisis will kick off in Alabama, Cici Yongshi Yu reports for Bloomberg Law. In their lawsuit, a group of eight Alabama hospitals argue that they have been on the front lines of treating victims of the opioid crisis and have borne a significant portion of the associated costs. The hospitals are seeking between $300 million and $500 million from the nine defendants, which include opioid manufacturer Johnson & Johnson and wholesale distributor AmerisourceBergen. Why it matters: The case marks the first opioid state trial involving hospitals in the country, which aims to expedite relief funds as federal litigation stalls. Similar lawsuits brought by hospitals are pending in state courts across the country, and the outcome of this case could signal how well their argument will fare in court. | | |  | From our reporters' notebooks | | The White House's pandemic office is finally here |  Maj. Gen. Paul Friedrichs, center, retired from the military this summer. He will be the first leader of the White House's new pandemic preparedness office. (Operation 2022/Alamy) | | | More than 200 days after President Biden signed it into law, it's official: The White House's pandemic office is up and running, the administration announced Friday. | | The Office of Pandemic Preparedness and Response Policy will be charged with leading the nation's response to major public health crises, starting first by absorbing the remaining work of the White House's covid-19 and mpox teams, our colleague Dan Diamond tells The Health 202. The White House also announced the nation's new pandemic czar: recently retired Maj. Gen. Paul Friedrichs, confirming The Washington Post's scoop. The longtime military health expert had won fans in the Biden administration for his work during the covid pandemic around rolling out vaccines and ramping up the global response. The news was generally cheered over the weekend. | - "Having a military guy in there sends a loud signal," retired senator Richard Burr (R-N.C.), a co-author of the legislation to create the office, told Dan. "When you look back at lessons learned [from covid], where we had the greatest problems were logistics, and I've got to believe that'll be the case next time."
| | How broad will the office's agenda be? The White House signaled the office's focus will go well beyond covid and mpox — with the administration also singling out threats like polio, avian and human influenza, and RSV — which prompted some chatter among public health experts who spoke with Dan this weekend. | - One open question: What happens if the health agencies and the White House's new pandemic office don't see eye-to-eye on the next crisis?
- Another: Does the White House's new office absorb the administration's work around biosafety, such as preventing future lab leaks?
| | Sen. Patty Murray (D-Wash.): |  | | | | | |  | Industry Rx | | Pfizer: Tornado damage at key plant mainly impacted storage facilities |  The plant produces critical injectable medicines for hospitals. (Travis Long/News & Observer/AP) | | | A tornado that tore through a key Pfizer pharmaceutical plant in North Carolina last week doesn't appear to have caused "any major damage" to areas that produce medicine, the company announced Friday, easing concerns that the incident could worsen existing drug shortages. A warehouse that stored raw materials, packing supplies and finished medicines awaiting release endured most of the twister's wrath. Even still, Pfizer CEO Albert Bourla said that restarting production at the plant could take weeks, Michael Erman and David Ljunggren report for Reuters. Why it matters: The Rocky Mount plant produces nearly 30 percent of all sterile injectable medicines that the company sells to U.S. hospitals, including anesthesia, painkillers and drugs to prevent infections. The Food and Drug Administration said Friday that it "doesn't expect any immediate significant impact" on supply given that the products are currently at hospitals and in the distribution system, but the agency has started asking other manufacturers to prepare to ramp up production if needed. | | |  | Daybook | | | 📅 Welcome back! The House and Senate are both in session for the last week before lawmakers are slated to break for the August recess. Here's what we're watching over the next few days: On Tuesday: President Biden is slated to deliver remarks on expanding access to mental health care. On Wednesday: The Senate HELP Committee will markup Chairman Bernie Sanders's (I-Vt.) bill to fund community health centers and expand the health workforce; the Senate Veterans' Affairs Committee will evaluate the implementation of legislation extending disability benefits to service members exposed to toxic substances. In the House, Health and Human Services Secretary Xavier Becerra will appear before an Energy and Commerce subcommittee to discuss his Office of Refugee Resettlement's management of unaccompanied migrant children; an Education and Workforce subcommittee will consider how school closures during the pandemic impacted students. On Thursday: The Joint Economic Committee will examine the economic impact of diabetes; the Senate Appropriations Committee will markup legislation to fund the Labor, Health and Human Services and Education departments through fiscal 2024, among other appropriations bills. Across the Capitol, White House drug czar Rahul Gupta will testify before the House Oversight and Accountability Committee on the Office of National Drug Control Policy's efforts to combat overdoses; a House Judiciary subcommittee will examine the Drug Enforcement Administration's response to the fentanyl and opioid crisis; a House Oversight and Accountability subcommittee will probe the Food and Drug Administration's lack of regulations for hemp-derived and cannabidiol (CBD) products; the House select subcommittee on the coronavirus pandemic will evaluate the science and impact of coronavirus vaccine mandates. | | |  | Health reads | | | By Sharon LaFraniere, Patricia Mazzei and Albert Sun | The New York Times ● Read more » | | | | | By Ilya Gridneff, Emily Schultheis and Dmytro Drabyk | Politico ● Read more » | | | | | |  | Sugar rush | | | Thanks for reading! See y'all tomorrow. | |
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