News Release 

Over 2 decades, the FDA consistently approved new opioids based on studies lacking critical safety approvals

Embargoed news from Annals of Internal Medicine

American College of Physicians

Research News

Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.

1. Over 2 decades, the FDA consistently approved new opioids based on studies lacking critical safety and efficacy data

Abstract: https://www.acpjournals.org/doi/10.7326/M20-0274

URL goes live when the embargo lifts

Over the past 2 decades, data submitted to the U.S. Food and Drug Administration (FDA) for new opioid approvals has lacked critical safety and efficacy information. During this timeframe, the FDA approved opioids on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations, excluding patients who did not tolerate the drug. Findings from a cross-sectional analysis are published in Annals of Internal Medicine.

Per capita use of opioids in the U.S. remains at epidemic levels and far exceeds that of other countries. Overdose rates are at an all-time high, mainly due to heroin and fentanyl use, but most users of those illicit drugs report that their first opioid was a prescription drug. Given the role that prescription opioids have played in driving the epidemic, the regulatory activities of the FDA have been scrutinized. Little is known about the evidence required by the FDA for new approvals of opioid analgesics.

Researchers from the Johns Hopkins Bloomberg School of Public Health studied 48 new drug applications (NDAs) for opioid analgesics submitted to the FDA between 1997 and 2018 to characterize the quality of safety and efficacy data included in the submissions. The researchers focused on drugs approved for chronic pain because of the heightened safety concerns with those drugs. The data showed that since 1996, the FDA has approved 48 NDAs for prescription opioids for pain. The NDAs were based on pivotal trials, none longer than 12 weeks, often in narrowly defined pain populations. Few approvals included or referenced pooled safety analyses that incorporated systematic assessments of opioid-associated risks, such as tolerance, drug diversion, and nonmedical use. Persons who did not respond to or otherwise tolerate a product were often excluded from the trials. According to the researchers, their findings suggest several opportunities for the FDA to use its regulatory discretion to increase the safety and efficacy data generated in support of new opioid approvals.

Media contacts: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To reach the corresponding author, G. Caleb Alexander, MD, MS, please contact Barbara Benham at bbenham1@jhu.edu.

2. Firearm injuries increase individual health care usage and costs by up to 20 times

Abstract: https://www.acpjournals.org/doi/10.7326/M20-0323

URL goes live when the embargo lifts

In the 6 months after a firearm injury, patient-level health care visits and costs increased by 3 to 20 times compared with the 6 months prior. These findings, published in Annals of Internal Medicine, demonstrate the substantial financial and personal burden of firearm injury on the U.S. health care system.

In 2018, approximately 40,000 persons died from a firearm injury, representing a 20 percent increase in the death rate since 2009. The number and effect of injuries are less well-determined. Although the health care-related cost of firearm injury is estimated to be high, prior data were largely cross-sectional, did not include data on preinjury and postinjury health care visits and related costs, and used hospital charges rather than actual monetary payments.

Researchers from Brown University studied insurance claims data from 5 Blue Cross Blue Shield plan states to compare actual monetary payments and health care utilizations within the 6 months before and after a firearm injury. They found that in the 6 months after a firearm injury, patient-level health care visits and costs were over $8 million for those who were shot, and seen in the emergency department; and over $41 million for those who were shot, and required admission to the hospital. Overall, healthcare costs for those who were shot increased by 3 to 20 times in the 6 months after an injury compared with the 6 months before it. The analysis did not measure intangible costs, such as lost wages, fear, and death.

The researchers also noted that although mental health claims increased by 100 to 300 percent after an injury (depending on whether a patient was discharged or admitted), these claims increased proportionally less than those for general health care. This may reflect the fact that mental health care is often received and paid for out of network, but more likely shows a lack of diagnosis and/or access to mental health care.

According to the researchers, these findings show that firearm injuries have a substantial impact on the U.S. health care system and should inform the prioritization of firearm injury prevention strategies.

Media contacts: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To reach the corresponding author, Megan L. Ranney, MD, MPH, please contact Maggie Spear at maggie_spear@brown.edu.

3. Acute care hospitals owned by private equity firms more likely to be in low-income, rural areas

Abstract: https://www.acpjournals.org/doi/10.7326/M20-1361

URL goes live when the embargo lifts

Private equity-owned acute care hospitals are more likely to be located in lower-income, more rural areas compared with non-private equity-owned hospitals, among other important differences. A study comparing the characteristics of the two types of hospitals is published in Annals of Internal Medicine.

Researchers from Harvard Medical School and Massachusetts General Hospital studied merger and acquisition reports by Irving Levin Associates and public information to identify 130 hospitals under private equity control in 2018 and compared them with similarly sized and located hospitals not owned by private equity firms. Comparisons were based on location, financial characteristics, and patient experience. The researchers found that private equity hospitals were on average were located in lower-income, more rural areas and had fewer patients discharged and employees per bed. They also had slightly lower patient experience scores. Several economic outcomes were similar and quality of care was not fully measured. According to the researchers, some of these differences may be due to unobserved factors, such as private equity-owned hospitals being located in less metropolitan areas with different populations and socioeconomic conditions than more metropolitan areas. They suggest more research to uncover these reasons.

Media contacts: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To reach the corresponding author, Zirui Song, MD, PhD, please contact him at Song@hcp.med.harvard.edu.

###

Also in this issue:

Ideas About Resourcing Health Care in the United States: Can Economic Evaluation Achieve Meaningful Use?
William V. Padula, PhD, and Mark J. Sculpher, PhD
Medicine and Public Issues
Abstract: https://www.acpjournals.org/doi/10.7326/M20-1234

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.