Jane R. Montealegre, PhD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the effectiveness of mailed at-home self-sampling for HPV testing in a safety-net health system setting. The analysis included data from 2115 patients who were randomly assigned to one of the 3 following arms: telephone recall to provider-performed screening (usual care; arm 1); telephone recall + mailed self-sampling kit for HPV testing (arm 2); or telephone recall + mailed self-sampling kit + telephone-based patient navigation (arm 3).

The researchers found that among participants, the median time since last screening test was 9.5 years. Screening participation across arms 1, 2, and 3 was 15.3, 44.0, and 51.4%, respectively. Compared with usual care (arm 1), the relative incidence of screening in arms 2 and 3 was 2.90 and 3.36, respectively. For arm 3 vs arm 2, the relative incidence of screening was 1.16.

“After US Food and Drug Administration approval, self-sampling for high-risk-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations,” the authors write.

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Laura Witt, from St. Joseph Hospital at Ruhr University in Bochum, Germany, and colleagues examined infant development during the first 36 months of life for infants of mothers receiving mAb for multiple sclerosis. A total of 183 mAb breastfed-exposed infants whose mothers had a diagnosis of multiple sclerosis or neuromyelitis optica spectrum disease were compared to 183 unexposed infants (controls). mAb exposure during breastfeeding started on a median of 19 days postpartum.

Breastfeeding participants most often received natalizumab, followed by ocrelizumab, rituximab, and ofatumumab (68.31, 18.58, 6.01, and 5.46%, respectively); while breastfeeding, 2 cases switched from natalizumab to ocrelizumab and one from rituximab to ocrelizumab. The researchers found that annual infant hospitalization, annual systemic antibiotic use, developmental delay, or weight at follow-up visits were not associated with mAb-exposed breastfeeding.

“Our data show infants exposed to these medications through breastfeeding experienced no negative effects on health or development within the first three years of life,” coauthor Kerstin Hellwig, MD, also from St. Joseph Hospital, said in a statement.

The study was partly funded by pharmaceutical companies.

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Viktor H. Ahlqvist, PhD, from the Karolinska Institutet in Stockholm, and colleagues conducted a nationwide cohort study with a sibling control analysis including a population-based sample of 2,480,797 children born in 1995 to 2019 in Sweden to examine the associations of acetaminophen use during pregnancy with children’s risk for autism, ADHD, and intellectual disability.

The researchers found that ever-use versus no use of acetaminophen during pregnancy was associated with a marginally increased risk for autism (hazard ratio, 1.05; 95% CI, 1.02 to 1.08), ADHD (hazard ratio, 1.07; 95% CI, 1.05 to 1.10), and intellectual disability (hazard ratio, 1.05; 95% CI, 1.00 to 1.10) in models without sibling control. Matched full-sibling pairs were also analyzed to address unobserved confounding. There was no evidence that acetaminophen use during pregnancy was associated with autism, ADHD, or intellectual disability in sibling control analyses. No evidence of a dose-response pattern was seen in sibling control analyses.

“This suggests that associations observed in models without sibling control may have been attributable to confounding,” the authors write.

One author disclosed ties to Neobiomics AB; a second author disclosed ties to law firms and AlphaSights.

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HealthDay News — For women with moderate-to-severe nausea and vomiting of pregnancy (NVP), both acupuncture and doxylamine-pyridoxine are efficacious, and the combination may yield a larger benefit than either treatment alone, according to a study published online June 20 in the Annals of Internal Medicine.

Xiao-Ke Wu, MD, PhD, from the Heilongjiang University of Chinese Medicine in Harbin, and colleagues examined the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in 352 women in early pregnancy with moderate-to-severe NVP. Participants received 30 minutes of daily active or sham acupuncture and 14 days of doxylamine-pyridoxine or placebo.

The researchers observed no significant interaction between the interventions. A larger reduction in the Pregnancy-Unique Quantification of Emesis score was seen over the treatment course for acupuncture, doxylamine-pyridoxine, and the combination of both compared with their respective control groups (mean differences, −0.7, −1.0, and −1.6, respectively). The risk for births with children who were small for gestational age was higher with doxylamine-pyridoxine vs placebo.

“The combination of both treatments showed numerically larger and potentially more clinically meaningful benefit than either treatment alone,” the authors write. “This finding is especially significant because there is a pressing need to establish a pregnancy-safe treatment regimen and an integrative guideline for managing severe NVP.”

One author disclosed ties to industry.

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The Food and Drug Administration (FDA) has approved Adacel^® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

The approval was based on a re-analysis of data from on observational study of Tdap vaccine effectiveness in the US (ClinicalTrials.gov Identifier: NCT05040802). Adacel was estimated to be 88% (95% CI, 43.8-97.4) effective in preventing pertussis in infants younger than 2 months when administered during the third trimester of pregnancy and at least 14 days before delivery based on data from 101 cases of pertussis in infants younger than 2 months of age (including 5 infants whose mothers received Adacel during the third trimester and ≥14 days before delivery) and 171 controls (including 27 infants whose mothers received Adacel during the third trimester and ≥14 days before delivery).

The FDA also reviewed data from a retrospective passive surveillance study (ClinicalTrials.gov Identifier: NCT00258882) that included women who received Adacel during pregnancy (n=225) and controls (n=675). Findings suggest that the rates of major birth defects and miscarriage in women who receive Adacel within 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates. There were 21 reports of spontaneous abortion (9.3%) and 15 congenital anomalies (6.7%) in the Adacel exposed group, and 102 spontaneous abortions (15%) and 57 congenital anomalies (8.4%) in the control group.

Adacel is administered as a single 0.5mL intramuscular injection. To prevent pertussis in infants younger than 2 months of age, Adacel should be administered to pregnant individuals during the third trimester of pregnancy. Pregnancy outcomes in women exposed to Adacel during pregnancy are monitored through a pregnancy exposure registry. Patients and health care providers are encouraged to contact Sanofi Pasteur at (800) 822-2463 or online at www.sanofipasteurpregnancyregistry.com.

Adacel is also indicated for active booster immunization against tetanus, diphtheria and pertussis in individuals 10 through 64 years of age.

Reference

Adacel. Package insert. Sanofi Pasteur Inc; 2023. Accessed January 11, 2023. https://www.fda.gov/media/119862/download.

HealthDay News — Neurodevelopment and growth in offspring is not negatively impacted by prenatal exposure to attention-deficit/hyperactivity disorder (ADHD) medication, according to a study published online February 9 in Molecular Psychiatry.

Kathrine Bang Madsen, PhD, from Aarhus University in Denmark, and colleagues assessed whether in utero exposure to ADHD medication was associated with adverse long-term neurodevelopmental and growth outcomes in offspring. The analysis included 898 children exposed to ADHD medication in utero and 1270 children whose mothers discontinued ADHD medication before pregnancy, who were born from 1998 to 2015 and followed through 2018.

After adjusting for demographic and psychiatric characteristics of the mother, the researchers observed no increased risk for any offspring developmental disorders for either combined (adjusted hazard ratio, 0.97; 95% CI, 0.81 to 1.17) or separate subcategories. In the negative control and sibling-controlled analyses, there was no increased risk seen for any subcategories of outcomes.

“We can see that the number of women of childbearing age who are medicated for ADHD is rapidly increasing, and therefore it is very important to garner more knowledge to be able to counsel these women,” a coauthor said in a statement. “There are still unknowns, but these results may contribute to women making informed decisions about using ADHD medication during pregnancy.”

Several authors disclosed financial ties to the pharmaceutical industry.

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(HealthDay News) — For women taking combined oral contraceptives (COCs), withdrawal during the pill pause is associated with adverse mental health symptoms, similar to those experienced during menses, according to a study published online Sept. 27 in JAMA Network Open.

Isabel A. Noachtar, from the University of Salzburg in Austria, and colleagues examined whether short-term hormonal withdrawal, which users of COCs undergo once a month (pill pause), is associated with altered mood and emotional recognition in a study involving women who used COC for 6 months or longer. The case-control study included a control group of women with natural menstrual cycles. The analysis included women aged 18 to 35 years (61 with androgenic COC use, 59 with antiandrogenic COC use, and 60 with a menstrual cycle not taking COCs).

The researchers found that COC users showed a 12.67%, 7.42%, and 23.61% increase in negative affect, anxiety, and mental health symptoms, respectively, during the pill pause vs the active intake phase. The effect size did not differ depending on progestin type or ethinylestradiol dose and was comparable with mood changes along the menstrual cycle among women with natural cycles.

Women with higher baseline depression scores had more pronounced mood worsening during the pill pause. There was no difference seen in emotion recognition performance for the active pill phase and pill pause.

“These results question the usefulness of pill pauses from a mental health perspective, and it should be explored whether long-term COC users benefit more from the mood-stabilizing effects of COCs in cases of continuous intake,” the authors write.

One author disclosed ties to the pharmaceutical industry.

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Increased rates of APOs are associated with rheumatic diseases like SLE, rheumatoid arthritis (RA), and dermatomyositis, but little is known about pregnancy outcomes among patients with ASDs. Therefore, researchers conducted a case-control study to assess the frequency of APOs among women with ASDs.

Data were taken from the TriNetX United States Collaborative Network database and included patients aged between 15 to 44 years who were pregnant, from January 1, 2016, to December 31, 2021.

Patients with ASDs were propensity score matched 1:1 with members of two control groups for comparison: 1) healthy patients without ASDs, RA, or SLE and 2) individuals with RA or SLE who were considered members of the disease-control group.

The study included 3654 patients with ASDs and 3654 members of the control groups (2147 patients with SLE and 889 with RA).

Patients with ASDs were at greater risk of experiencing spontaneous abortion and preeclampsia/eclampsia compared with members of the healthy control group.

Specifically, the risk for spontaneous abortion was 1.5 times higher among patients with ASDs than in the healthy control group (P <.001), while the risk for preeclampsia/eclampsia was 1.2 times higher among patients with ASDs compared with the healthy control group (P =.04).

Compared against women with SLE, women with ASDs were less likely to experience preeclampsia/eclampsia, have a preterm birth, experience preterm premature rupture of membranes (PPROM), or have a fetus with intrauterine growth restriction (IUGR).

Specifically, the risk for preeclampsia/eclampsia was 0.7 times lower (P =.001), the risk of delivering preterm was 0.5 times lower (P <.001), the risk for PPROM was 0.6 times lower (P =.004), and the risk of having a fetus with IUGR was 0.6 times lower (P <.001) among women with ASDs vs women with SLE.

Women with ASDs were more 1.2 times more likely to experience a spontaneous abortion than women with SLE (P =.003). Patients with ASDs and RA were at similar risk for APOs.

The study authors concluded, “These results suggest that patients with ASDs have increased rates of adverse pregnancy outcomes compared to healthy controls and are similar in risk to RA. In contrast, those with SLE have a greater frequency of APOs indicating that all these groups may benefit from multidisciplinary care with maternal-fetal medicine specialists.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

HealthDay News — Age, race, and education are the most prevalent disparities associated with menopausal hormone therapy (MHT) prescribing, according to research presented at the annual meeting of the North American Menopause Society, held from September 27 to 30 in Philadelphia.

Danette Conklin, PhD, from University Hospitals in Cleveland, and colleagues conducted a scoping review of real-world studies to examine health care disparities in MHT prescribing based on demographic or clinical characteristics. The scoping review included 20 studies conducted from 1973 through 2015.

The researchers found that age, race, and education were the three most prevalent disparities associated with MHT. In 13 studies, age was associated with MHT disparities, with older women being prescribed, using, or being counseled on MHT more often than younger women in seven studies. In four studies, older women were prescribed, used, or were counseled on MHT less than younger women, while mixed results were seen in one study. Ten studies reported race disparities; all reported that Black women used, were prescribed, or were counseled less than their White, Mexican, Latina, or Asian counterparts. Compared with all other races, White women received/used MHT more often, with the exception of vaginal estrogen, which was prescribed to White women less than Hispanic menopausal women in one study. Six studies demonstrated educational disparities, with menopausal women with less versus more education counseled less and using or prescribed less MHT.

“This study reinforces that health care professionals must ask patients about their specific menopause symptoms so they can discuss the options that could help them improve their quality of life,” Stephanie Faubion, MD, medical director of the North American Menopause Society, said in a statement. “Black women should have the same access as White women to the available treatment options.”

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Jamie Kitt, DPhil, from the University of Oxford in the United Kingdom, and colleagues assessed whether remote self-monitoring and physician-guided titration of antihypertensive medications using a Bluetooth-enabled app provides better long-term blood pressure control than usual outpatient care during the first nine months postpartum. The analysis included 200 participants randomly assigned following a hypertensive pregnancy.

The researchers found that the 24-hour mean diastolic blood pressure, measured at 249 days postpartum, was 5.8 mm Hg lower in the intervention group (71.2 vs 76.6 mm Hg) than in the control group (between-group difference, −5.80 mm Hg). Similar results were seen for 24-hour mean systolic blood pressure (114.0 vs 120.3 mm Hg; between-group difference, −6.51 mm Hg).

“An intervention that lowers blood pressure by 5 mm Hg would be expected to delay progression to hypertension by many years and, over a lifetime, reduce risk of cardiovascular or cerebrovascular events,” the authors write.

Two authors disclosed financial ties to Sensyne Health.

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Govenor Kay Ivey, a Republican, signed the bill into law shortly after it was passed by the Senate on Wednesday.

Following the signing, 2 major fertility clinics said they will restart IVF treatments while another clinic said the scope of protections was unclear and it would wait for “legal clarification,” the New York Times reported.

Lawmaker support for the bill was strong, 81 to 12, with 9 abstentions, in the House and 29 to 1 in the Senate, the Times reported.

Why was the legislation passed so quickly?

The state Supreme Court ruling raised fears about civil and criminal liability among infertility doctors and clinics.

Shortly after the ruling was issued, at least three major clinics stopped IVF treatments and an embryo shipping company paused its business in the state, the Times reported. Meanwhile, IVF patients pleaded with lawmakers and protested to preserve their right to grow their families.

The new law stops short of addressing whether a frozen embryo conceived outside of the womb should be considered a person. Instead, it broadly shields clinics and IVF providers from civil and criminal liability.

“The problem we’re trying to solve right now is to get those families back on a track to be moving forward as they try to have children,” said State Rep. Terri Collins, who sponsored the measure in the House. “Will we need to address that issue? Probably.”

“I don’t want to define life, that’s too important to me, to my faith,” Collins told the Times. “But we do have to decide where we begin protection, and that’s what I think we’ll have to talk about.”

Meanwhile, Infirmary Health Systems and the Center for Reproductive Medicine, the targets in the wrongful death lawsuit that led to the state Supreme Court ruling, said it would not yet resume IVF treatments, the Times reported.

“At this time, we believe the law falls short of addressing the fertilized eggs currently stored across the state and leaves challenges for physicians and fertility clinics trying to help deserving families have children of their own,” a statement from the clinic said.

Experts agreed that the legal picture on IVF is still murky.

“The question that’s answered by this bill is, are our fertility clinics liable?” Clare Ryan, a professor of family law at the University of Alabama, told the Times. “It doesn’t address these bigger questions about, what is the child? When does the act of conception occur? What is the role of uterine implantation?”

“Republicans created this mess for themselves, and now they’re trying to contain the damage from it without dealing with the mess itself,” said Susan Pace Hamill, a University of Alabama law professor who specializes in the state Constitution, told the Times. “They are doing back somersaults to avoid disturbing directly anything the Alabama Supreme Court said.”

More information

Visit Yale Medicine for more on IVF.

SOURCE: New York Times

In the decision, judges turned to what it called anti-abortion language in that state’s constitution and concluded that an 1872 state law that allows parents to sue over the death of a minor child “applies to all unborn children.”

“Unborn children are ‘children’ … without exception based on developmental stage, physical location, or any other ancillary characteristics,” Associate Justice Jay Mitchell wrote in the ruling.

Reaction to the decision was swift and strident, as infertility experts stressed the ruling ultimately threatens the use of IVF treatments.

“By insisting that these very different biological entities are legally equivalent, the best state-of-the-art fertility care will be made unavailable to the people of Alabama. No health care provider will be willing to provide treatments if those treatments may lead to civil or criminal charges,” Dr Paula Amato, president of the American Society for Reproductive Medicine, told the Associated Press.

“This ruling is stating that a fertilized egg, which is a clump of cells, is now a person. It really puts into question the practice of IVF,” Barbara Collura, CEO of RESOLVE: The National Infertility Association, told the AP.

The decision is a “terrifying development for the 1-in-6 people impacted by infertility” who need in-vitro fertilization, she said.

Following the ruling, it isn’t clear whether future embryos created during fertility treatments can be frozen or if patients could ever donate or destroy unused embryos.

But Sean Tipton, a spokesman with the American Society for Reproductive Medicine, told the AP that at least one Alabama fertility clinic has been instructed by their affiliated hospital to pause IVF treatment for now.

The plaintiffs in the Alabama case had IVF treatments that created several embryos, some of which were implanted and led to healthy births, the AP reported. The couples paid to keep the unused embryos frozen in a storage facility, but a patient managed to wander into the area in 2020 and removed several embryos, dropping them on the floor and “killing them,” the ruling said.

The justices ruled that the wrongful death lawsuits brought by the couples could proceed, although the clinic and hospital named as defendants in the case could appeal.

Michael Upchurch, a lawyer for the fertility clinic in the lawsuit, the Center for Reproductive Medicine, told the AP they are “evaluating the consequences of the decision and have no further comment at this time.”

Meanwhile, an anti-abortion group applauded the decision.

“This ruling, which involved a wrongful-death claim brought by parents against a fertility clinic that negligently caused the death of their children, rightly acknowledged the humanity of unborn children created through in vitro fertilization [IVF] and is an important step towards applying equal protection for all,” Lila Rose, president and founder of Live Action said in a statement.

Justice Greg Cook, who filed the only full dissent to the ruling, said the 1872 law was being stretched from its original intent to cover frozen embryos.

“No court, anywhere in the country, has reached the conclusion the main opinion reaches,” he wrote, adding the ruling “almost certainly ends the creation of frozen embryos through in vitro fertilization [IVF] in Alabama.”

White House press secretary Karine Jean-Pierre said Tuesday that the Alabama decision was yet another consequence of the US Supreme Court overturning Roe v. Wade in June 2022, the AP reported.

“This president and this vice president will continue to fight to protect access to reproductive health care and call on Congress to restore the protections of Roe v. Wade in federal law for all women in every state,” Jean-Pierre told reporters.

More information

The World Health Organization has more on abortion.

SOURCE: Associated Press

HealthDay News — The first over-the-counter birth control pill is slated to hit drug stores in early 2024, but questions about cost and insurance coverage loom.

The US Food and Drug Administration approved Opill (norgestrel) for preventing pregnancy without a prescription in July, but pill maker Perrigo has yet to announce the price of the contraceptive. So far, only 6 states require coverage of some OTC birth control methods: California (effective in 2024), Maryland, New Jersey, New Mexico, New York, and Washington, according to KFF.

To get ahead of any potential access issues before Opill is rolled out, KFF researchers conducted interviews with 80 stakeholders from private insurance plans, state Medicaid programs, and chain pharmacies in the states that already require such coverage. They found that people will generally need to get Opill at the pharmacy counter, as opposed to off the shelves, for their plan to cover it. In some private health plans, people may be able to pay for Opill at the cashier and then seek reimbursement from their plan.

“The current system is designed for covering prescription, not OTC, drugs, and there is a lack of uniformity in billing practices which leads to confusion among many key players,” Michelle Long, a senior policy analyst for Women’s Health Policy at KFF, said during a recent KFF news conference on insurance coverage of OTC birth control. There is also an awareness gap. “Few plans provide information about this covered benefit to enrollees in enrollee-facing materials,” Long said.

There is also a need for greater awareness among pharmacists, said Don Downing, a clinical professor at the University of Washington School of Pharmacy in Seattle. Pharmacists need to know there is no age restriction and no parental consent needed for Opill (unless such restrictions are imposed in given states), Downing said during the news conference.

There is no nationally accepted claims processing system for pharmacists to use for OTC contraceptives, he added. Streamlining this process should include creating a universal dummy National Provider Identifier. Another option is for states to issue standing orders, which assert that a pharmacist is not prescribing but just fulfilling a preauthorized request to provide a product. With standing orders, pharmacists will not be filling out claims information and cannot be held liable, as they could be if they were prescribing the product.

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Cynthia Gyamfi-Bannerman, MD, from the University of California, San Diego, and colleagues evaluated whether administration of late preterm (34 to 36 completed weeks) corticosteroids (12mg of intramuscular betamethasone administered twice 24 hours apart) to persons at risk for late preterm delivery affected childhood neurodevelopmental outcomes. The analysis included 949 children aged 6 years and older followed from birth as part of the Maternal-Fetal Medicine Units Network cycle.

The researchers found no differences in the primary outcome of a general conceptual ability score less than 85, which occurred in 17.1% of the betamethasone group vs 18.5% of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73 to 1.22). Similarly, there no differences in secondary outcomes of gross motor skills, social responsiveness, or behavior.

“In this follow-up study of a randomized clinical trial, antenatal corticosteroids in persons at risk of late preterm delivery were not associated with adverse effects on childhood neurodevelopmental outcomes at age 6 years or older,” the authors write. “These data provide reassurance with regard to the administration of antenatal corticosteroids in the late preterm period.”

One author disclosed ties to the pharmaceutical industry.

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HealthDay News — The abortion pill mifepristone should remain legal in the US, but with significant restrictions on access to it, a federal appeals court ruled Wednesday. The decision, issued by the US Court of Appeals for the Fifth Circuit in New Orleans, effectively sets the stage for a showdown before the Supreme Court on the fate of the drug.

The lower court ruling from Texas that the federal appeals court weighed would have fully revoked the US Food and Drug Administration approval of the medication back in 2000. Instead, this latest decision will end availability of the drug by mail or telemedicine. The three-judge panel also said mifepristone can only be used through 7 weeks, instead of 10, and the drug will be required to be administered with a doctor present, the Associated Press reported.

“In loosening mifepristone’s safety restrictions, [the] FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” wrote Judge Jennifer Walker Elrod, a George W. Bush appointee to the Fifth Circuit.

But the American Medical Association (AMA) took issue with the new ruling. “Today’s decision by the Fifth Circuit Court of Appeals continues to signal a move in the wrong direction on access to mifepristone, potentially eliminating the ability to prescribe and dispense mifepristone via telemedicine and reinstating barriers to access that lack scientific evidence,” Jack Resneck, MD, immediate past president of the AMA, said in a statement. “While this decision preserves the original approval of Mifeprex and generic mifepristone, this action will undoubtedly negatively impact patients across the country if left in place.”

However, none of the restrictions will happen yet because the Supreme Court intervened in April to allow availability of the drug while the Texas case works its way through the courts. The Supreme Court, which will likely act in the coming months, could deny review, leaving in place the appeals court’s ruling, curbing access to the pill. Or it could agree to hear the appeal, throwing the future of the abortion pill in doubt, The New York Times reported.

The original Texas lawsuit was filed by conservative Christian group the Alliance Defending Freedom (ADF). An earlier lawsuit filed by that group led to the Supreme Court’s decision to overturn Roe v. Wade after nearly 5 decades.

Reacting to the news, the alliance issued a statement applauding the ruling. “The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” said ADF Senior Counsel Erin Hawley, who is also vice president of the ADF Center for Life and Regulatory Practice. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen.”

Health care providers have said they will switch to using only the other drug used in the typically two-drug medication abortions. That medication, misoprostol, is somewhat less effective, the AP reported.

Associated Press Article

The New York Times Article