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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 21, 2020

Media advisory: To contact corresponding author David G. Strauss, M.D., Ph.D., email Amanda Turney at Amanda.Turney@fda.hhs.gov and Brittney Manchester at brittney.manchester@fda.hhs.gov.  The full study and editorial are linked to this news release. A visual abstract is below.

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Bottom Line: A randomized clinical trial with 48 healthy volunteers assessed the absorption of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate) in four sunscreen products formulated as lotion and sprays (aerosol, nonaerosol and pump). This study builds on a prior trial from Food and Drug Administration (FDA) researchers published by JAMA in 2019. In this trial, all six tested active ingredients administered in four different sunscreen formulations were absorbed and had blood concentrations that surpassed the FDA threshold for potentially waiving some of the additional safety studies for sunscreens. Researchers emphasize the findings don’t mean people should refrain from using sunscreen, which can help to prevent skin cancer and protect the skin. More research is needed to determine the effect of exposure to sunscreen ingredients. This study was conducted indoors in a clinical research setting and participants weren’t exposed to direct sunlight during the seven days they remained at the clinic. A change in study design from an indoor to an outdoor setting would better represent real-life sunscreen application. The study also wasn’t designed to assess the absorption difference by formulation or skin types.

Authors: David G. Strauss, M.D., Ph.D., U.S. Food and Drug Administration, Silver Spring, Maryland, and coauthors.

Visual Abstract:

(doi:10.1001/jama.2019.20747)

Editor’s Note: The study was funded by the FDA. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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JAMA

EMBARGOED FOR RELEASE: 4:30 A.M. (ET), FRIDAY, JANUARY 17, 2020

Media advisory: The full study and editorial are linked to this news release. A visual abstract is below. The study is being released to coincide with presentation at the Critical Care Reviews Meeting 2020 in Belfast, Northern Ireland. The live presentation can be viewed here https://vimeo.com/383968980.

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What The Study Did: Researchers report on a randomized clinical trial that compared two strategies (proton pump inhibitors vs. histamine-2 receptor blockers) to prevent stress ulcers among adult patients in intensive care units who needed mechanical ventilation. The trial was conducted at 50 ICUs in five countries to compare in-hospital death rates using the two strategies. The study is being released to coincide with presentation at the Critical Care Reviews Meeting 2020 in Belfast, Northern Ireland.

Authors: Paul J. Young, Ph.D., of the Medical Research Institute of New Zealand in Wellington, is the corresponding author.

Visual Abstract

(doi:10.1001/jama.2019.22190)

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JAMA

EMBARGOED FOR RELEASE: 6:30 A.M. (ET), FRIDAY, JANUARY 17, 2020

Media advisory: The full study and editorial are linked to this news release. A visual abstract is below. The study is being released to coincide with presentation at the Critical Care Reviews Meeting 2020 and the live presentation can be viewed here https://vimeo.com/383969217.

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What The Study Did: In this randomized clinical trial of about 200 patients with septic shock, combination treatment with intravenous vitamin C, hydrocortisone and thiamine compared with intravenous hydrocortisone alone didn’t significantly improve the amount of time patients were alive and free of medicines that raise blood pressure (vasopressors) over seven days. The study findings are being released to coincide with presentation at the Critical Care Reviews Meeting 2020 in Belfast, Northern Ireland.

Authors: Rinaldo Bellomo, M.D., Ph.D., of Monash University in Melbourne, Australia, is the corresponding author.

Visual Abstract

(doi:10.1001/jama.2019.22176)

Editor’s Note: The article includes conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 14, 2020

Media advisory: To contact corresponding author J. Kellogg Parsons, M.D., M.H.S., email Yadira Galindo at ygalindo@health.ucsd.edu. The full study and related study are linked to this news release. A visual abstract is below.

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Bottom Line: This randomized clinical trial among more than 400 men with early-stage prostate cancer looked at whether a telephone-based program encouraging increased vegetable consumption would decrease cancer progression over two years. The authors report no significant decrease in the risk of prostate cancer progression among men in the intervention program compared with those who received only written information about diet and prostate cancer. The study may have been underpowered to identify a clinically important difference.

Authors: J. Kellogg Parsons, M.D., M.H.S., UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California, and coauthors.

Visual Abstract

(doi:10.1001/jama.2019.20207)

Editor’s Note: The article includes conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 14, 2020

Media advisory: To contact corresponding author Jonathan J. Darrow, S.J.D., J.D., M.B.A., email Elaine St. Peter at estpeter@bwh.harvard.edu. The full study and editorial are linked to this news release.

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Bottom Line: Publicly available and Food and Drug Administration (FDA) data were used in this observational study to describe the number and types of prescription drugs approved from 1983 to 2018 and how the approval process and regulation of drugs changed during this period. Approvals of new generic drugs and biologics increased over this time, as the median annual number of generic drugs approved was 284 from 1985 to 2012 and 588 from 2013 to 2018. The authors report that the average annual number of new drug approvals, including biologics, was 34 from 1990-1999, decreasing to 25 from 2000-2009, and increasing to 41 from 2010-2018. There has been an expansion in the number of expedited development and approval programs since 1983, while the amount of evidence used for approvals has decreased. The proportion of new approvals supported by at least two pivotal trials declined from 81% in 1995-1997 to 53% in 2015-2017. The amount of industry-paid user fees collected, funds used to accelerate review times, have increased to an annual average of $820 million in 2013-2017. FDA drug review times declined from more than three years in 1983 to less than one year in 2017. A limitation of the study is the difficulty in comparing the size of the clinical benefit of drugs across different indications and populations.

Authors: Jonathan J. Darrow, S.J.D., J.D., M.B.A., of Brigham and Women’s Hospital, Harvard Medical School, Boston, and coauthors.

(doi:10.1001/jama.2019.20288)

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 7, 2020

Media advisory: The full study and editorial are linked to this news release.

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What The Study Did: Researchers pooled data from four large study groups with 250,000 women to estimate the association between using body powder in the genital area and risk of ovarian cancer.

Authors: Katie M. O’Brien, of the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina, is the corresponding author.

(doi:10.1001/jama.2019.20079)

Editor’s Note: The article includes conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 7, 2020

Media advisory: The full study is linked to this news release. A visual abstract is below.

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What The Study Did: This randomized clinical trial examined the effects of daily folic acid and zinc supplementation in men on semen quality and live births among 2,300 couples planning infertility treatment.

Authors: Enrique F. Schisterman, Ph.D., of the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Maryland, is the corresponding author.

Visual Abstract

(doi:10.1001/jama.2019.18714)

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, JANUARY 7, 2020

Media advisory: The full study is linked to this news release.

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What The Study Did: This study assessed changes between 2008 and 2018 in the rate of cesarean deliveries in China.

Authors: Jian-meng Liu, Ph.D., of the Peking University Health Science Center in Beijing, is the corresponding author.

(doi:10.1001/jama.2019.17595)

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), FRIDAY, DECEMBER 20, 2019

Media advisory: To contact corresponding author Jennifer L. Marti, M.D., email Grace Naugle at gen4001@med.cornell.edu. The full study is linked to this news release.

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Bottom Line: An analysis suggests rates of thyroid cancer in the U.S. appear to have plateaued in recent years after decades on the rise. That increase was mostly attributed to more screening and imaging over the last three decades that detected many small thyroid cancers. Researchers in this observational study used cancer surveillance registry data to examine changes in rates of new cases of thyroid cancer in the U.S. from 1992 to 2016. Authors report the rate increased from 5.7 to 13.8 per 100,000 between 1992 and 2009, with the greatest annual percentage change (6.6%) from 1998 to 2009. The rate of increase slowed from 2009 to 2014 (13.8 to 14.7 per 100,000) and the rate has been stable since 2014 (from 14.7 to 14.1 per 100,000). The rate changes possibly may be due to a decline in the occurrence of thyroid cancer but the changes happened when there was a greater understanding about overdiagnosis of thyroid cancer and practice guidelines changed so a less intensive workup of thyroid nodules is a more likely explanation. Limitations of the study include that observational analyses like these cannot determine causality and the results may not be generalizable to other areas of the U.S. beyond the regions included in the registry data.

Authors: Jennifer L. Marti, M.D., Weill Cornell Medicine, New York, and coauthors.

(doi:10.1001/jama.2019.18528)

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), FRIDAY, DECEMBER 20, 2019

Media advisory: To contact corresponding author Yiling J. Cheng, M.D., Ph.D., email Alaina Robertson at ifs2@cdc.gov. The full study and editorial are linked to this news release.

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Bottom Line: Estimating how common diabetes (both diagnosed and undiagnosed) was among U.S. adults by racial and ethnic groups was the objective of this observational study. A group of 7,575 adults 20 and older who participated in the National Health and Nutrition Examination Surveys between 2011-2016 were included. Among them, 2,266 people had diagnosed diabetes, and 377 had undiagnosed diabetes. The age-sex-adjusted proportion of adults with diabetes (diagnosed and undiagnosed) was 12.1% non-Hispanic white, 20.4% non-Hispanic black, 22.1% Hispanic, and 19.1% non-Hispanic Asian. The results also show that among selected Hispanic and non-Hispanic Asian subpopulations, there were noteworthy differences in how common diabetes was. The age-sex-adjusted proportion of adults with undiagnosed diabetes was 3.9% non-Hispanic white, 5.2% non-Hispanic black, 7.5% Hispanic, and 7.5% non-Hispanic Asian. Limitations of the study include diagnosed diabetes was self-reported, and there was a small sample of adults in some subgroups used for estimates.

Authors: Yiling J. Cheng, M.D., Ph.D., Centers for Disease Control and Prevention, Atlanta, and coauthors.

(doi:10.1001/jama.2019.19365)

Editor’s Note: The article includes conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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JAMA

EMBARGOED FOR RELEASE: 12 A.M. (ET), WEDNESDAY, DECEMBER 18, 2019

Media advisory: To contact corresponding author Hongying Dai, Ph.D., email Vicky Cerino at vcerino@unmc.edu. The full study is linked to this news release.

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Bottom Line: Marijuana use in electronic cigarettes increased among U.S. middle and high school students from 2017 to 2018. This observational study analyzed responses from 38,000 students in the sixth to 12th grades on the National Youth Tobacco Survey. Researchers report that among all students, the proportion who reported ever using marijuana in an e-cigarette increased from 11.1% in 2017 to 14.7% in 2018, with the increases seen among some demographic groups, including male and female students, adolescents 13 to 17, high-schoolers, and non-Hispanic white and Hispanic students. In 2018, 42.7% of students who ever used e-cigarettes, 53.5% of current e-cigarette users, and 71.6% of multiple tobacco product users reported ever using marijuana in e-cigarettes. A limitation of the study is that the information was self-reported. Studies about the short- and long-term health effects of using marijuana in e-cigarettes are needed.

Author: Hongying Dai, Ph.D., University of Nebraska Medical Center, Omaha

(doi:10.1001/jama.2019.19571)

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JAMA

EMBARGOED FOR RELEASE: 12 A.M. (ET), WEDNESDAY, DECEMBER 18, 2019

Media advisory: To contact corresponding author Richard A. Miech, Ph.D., email Nick Prieur at nprieur@umich.edu. The full study is linked to this news release.

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Bottom Line: Marijuana vaping reported by U.S. adolescents increased from 2018 to 2019. This observational study used annual Monitoring the Future surveys from a nationally representative group of eighth, 10th and 12th graders to examine changes in marijuana vaping among adolescents. In 2019, past 30-day marijuana vaping was reported by 14% of 12th graders, an absolute increase of 6.5% from 2018. Additionally, 3.9% of 8th graders reported past 30-day use, an absolute increase of 1.3% from 2018 to 2019, and 12.6% of 10th graders reported such use in 2019, an absolute increase of 5.6% over 2018. One-year increases from 2018 to 2019 were larger than the increases from 2017 to 2018 for 10th and 12th graders for past 30-day use. Limitations of the study include potential errors in self-reported use and an absence of high-school dropouts. The growth in marijuana vaping suggests new prevention and intervention efforts aimed specifically at adolescents are needed.

Authors: Richard A. Miech, Ph.D., University of Michigan, Ann Arbor, and coauthors.

(doi:10.1001/jama.2019.20185)

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 17, 2019

Media advisory: To contact corresponding author Mark Olfson, M.D., M.P.H., email Gregory Flynn at Gregory.Flynn@nyspi.columbia.edu. The full study is linked to this news release.

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Bottom Line: Researchers analyzed changes in the proportion of drug overdose deaths involving opioids that were certified as suicide, unintentional or of undetermined intent in this observational study. Using 2000-2017 mortality data, researchers report 47,506 total opioid deaths (excluding homicides) in 2017: 90.6% were unintentional deaths, 4% were suicides and 5.4% were of undetermined intent. Between 2000 and 2017, the percentage of opioid-related deaths that were suicides declined from 9% to 4%; unintentional opioid-related deaths increased from 73.8% to 90.6%; and deaths of undetermined intent decreased from 17.2% to 5.4%. There were significant increases in opioid-related suicide rates for males and females, all racial/ethnic groups, and all age groups except those between the ages of 35 and 44. Between 2000 and 2017, the rate of opioid-related deaths increased from 2.2 to 13.2 per 100,000 people for unintentional deaths and from 0.27 to 0.58 per 100,000 for suicides with no significant change in the rate for deaths of undetermined intent. Limitations of the study include fewer drug overdose deaths that didn’t have information on the specific drug because of increased toxicological screening and that may have contributed to the increase in opioid-related deaths over time, as well as uncertainty about determinations made by coroners or medical examiners about the manner of death.

Authors: Mark Olfson, M.D., M.P.H., Columbia University Vagelos College of Physicians and Surgeons, New York, and coauthors.

(doi:10.1001/jama.2019.16566)

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JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), TUESDAY, DECEMBER 10, 2019

Media advisory: To contact the U.S. Preventive Services Task Force, email the Media Coordinator at Newsroom@USPSTF.net or call 202-572-2044. The full report, related articles and a podcast are linked to this news release.

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Bottom Line: The U.S. Preventive Services Task Force (USPSTF) has updated its recommendations on screening for an abdominal aortic aneurysm and the recommendations vary depending on factors such as patient age, sex and if they ever smoked. An abdominal aortic aneurysm is an enlarged area of the main blood vessel that supplies blood to the body and it can be life-threatening if it bursts. The USPSTF routinely makes recommendations about the effectiveness of preventive care services and this statement updates its 2014 recommendations.

(doi:10.1001/jama.2019.18928)

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Note: More information about the U.S. Preventive Services Task Force, its process, and its recommendations can be found on the newsroom page of its website.

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