Lawsuit Targets Publishers: Is Peer Review Flawed?

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.

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Dr. Amol Soin will be CEO of Alyea Therapeutics, which will become its own public company in the first half of 2025 under Alyea Therapeutics. The company plans to develop a Low Dose Naltrexone (LDN) with a biphasic release formulation that the company plans to pursue through the FDA. 

MedPAC Commissioners Pan Some Medicare Advantage Plans' 'Extra Benefits'

Services cost Medicare an extra $83B in 2024; are debit cards and groceries really healthcare?

A report detailing flaws with the "extra benefits" Medicare Advantage (MA) plans offer generated passionate debate Thursday during a meeting of the Medicare Payment Advisory Commission (MedPAC), with many commissioners questioning the value of spending $83 billion -- $2,500 per MA enrollee -- of taxpayer money for them each year.

"Beneficiaries are attracted to these extra benefits, and may join Medicare Advantage because of them, and yet the evidence kind of shows that use of these extra benefits is low," said commission member Tamara Konetzka, PhD, a professor of public health sciences at the University of Chicago. "There's vision here, or there's dental, and then they find that the benefits actually don't amount to much, or ... they have trouble finding providers in their network and using that benefit, or they were kind of mistaken about how important that is relative to the other things, other healthcare they need."

The MedPAC report the commissioners reviewed was not made public, but snippets were summarized in a 20-page presentation that MedPAC senior analyst Stuart Hammond and research assistant Pamina Mejia narrated. "The data that Medicare collects are insufficient for examining the use of services provided as supplemental benefits, and the lack of reliable data makes it impossible to answer many important questions about how the rebates Medicare pays to MA plans are used," Hammond told the commissioners.

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Dr. Annu Navani, a leader in interventional and regenerative medicine, is releasing a new book entitled "The Future of Your Health".

The purpose of this book is to help readers understand emerging treatments like gene therapy, robotics, and AI. As Chief Medical Officer at Boomerang Health Care, Dr. Navani brings years of expertise to this transformative guide.

Abstract submissions are open for ASIPP's 2025 Annual Meeting!

The abstract submission deadline is March 10, 2025. 

Don't miss this opportunity to share your insights and

help shape the future of pain management.

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FDA Warns Doctor Over Stem Cell Company

Agency says adipose-derived stem cell treatment should be regulated as a drug and biologic

The FDA has sent a warning letter to a company charging that its adipose-derived stem cell treatments -- known as stromal vascular fraction (SVF) -- are both a drug and a biologic and need to be regulated as such.

The letter is addressed to Florida-based Mother Stem Institute founder Alvaro Skupin, MD.

Mother Stem appears to have garnered the agency's attention in part because of claims on its website that its SVF product can treat Alzheimer's disease, type 1 and 2 diabetes, lupus, and rheumatoid arthritis, despite a lack of evidence for those claims, Paul Knoepfler, PhD, a stem cell biologist at the University of California Davis, wrote in a recent blog post.

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Peer Reviewers Have Financial Conflicts, Too

Majority reviewing for top medical journals had conflicts, and they made $1 billion in 3 years

More than half of peer reviewers for four top medical journals received payments from drug and medical device manufacturers, totaling $1.06 billion, from 2020 to 2022, according to an analysis of the Open Payments database.

Among nearly 2,000 physician peer reviewers at JAMA, the New England Journal of Medicine, The BMJ, and The Lancet, 58.9% received at least one industry payment during that period, including 54% who accepted general payments and 31.8% who accepted research payments, reported Christopher Wallis, MD, PhD, of the University of Toronto, and colleagues in a research letter in JAMA.

The $1.06 billion in industry payments included $1 billion (94%) to physicians or their institutions and $64.18 million (6%) in general payments. Consulting fees and speaking compensation unrelated to continuing medical education programs accounted for $34.31 million and $11.80 million, respectively.

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Poor Arm Position May Significantly Skew BP Readings

Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.

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Crackdowns on Unproven Stem Cell Therapies Worked Abroad

In Australia and Canada, most companies disappeared from the market or changed their claims

Evidence from Australia and Canada indicated that regulation can help to curb the sale of unproven stem cell therapies, researchers found.

Direct-to-consumer marketplaces experienced "marked decreases" in the number of companies selling such products following the introduction of regulatory reforms in both countries, reported Leigh Turner, PhD, of the University of California, Irvine, and colleagues.

In Australia, for example, medical regulators tightened rules over the advertising and provision of autologous cell and tissue products in 2018. These reforms clarified that direct-to-consumer marketing of such products is prohibited, and that reporting adverse events associated with the use of such products is mandatory.

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Virtual

October 26, November 9,

and December 14

Click here for the complete list of upcoming exams.

ABIPP Part I; ABIPP Path - Combined DCCPM/CSM virtual exam;

ABIPP Competency Exam in IPM; ABIPP Competency Exam in Regenerative Medicine;

CSM Competency Exam; DCCPM Competency Exam

Clonidine Comparable to Morphine for Infants With Opioid Withdrawal

Randomized trial showed no significant differences in length of treatment, neurobehavioral scores

Length of treatment and neurobehavioral scores did not significantly differ between infants with prenatal opioid exposure randomized to either clonidine or morphine, researchers found.

Among infants with neonatal opioid withdrawal syndrome (NOWS), median length of treatment was 15 days for infants who received morphine and 17 days for those who received clonidine (P=0.48), reported Henrietta Bada, MD, MPH, of the University of Kentucky in Lexington, and colleagues.

At the end of treatment, neurobehavioral performance, a predictor of childhood outcomes, also did not differ between groups, Bada and colleagues noted in Pediatrics.

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ASIPP's 2025 Annual Meeting

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Stop the Medicare Payment Cut and Pass a Permanent Fix, House Members Urge Leaders

The Medicare fee schedule is "inherently broken," says bipartisan letter from 233 members

A majority of House members urged House leaders to not only reverse a proposed 2.8% cut in the Medicare Physician Fee Schedule (MPFS), but also to pass a law that would avoid such cuts in the future.

"Increased instability in the healthcare sector due to looming cost hikes impacts the ability of physicians and clinicians to provide the highest quality of care and threatens patient access to affordable healthcare," read a bipartisan letter signed by 233 House members and spearheaded by Reps. Mariannette Miller-Meeks, MD (R-Iowa) and Jimmy Panetta (D-Calif.). "In lieu of these harmful cuts, which, absent federal legislation, will take effect on January 1, 2025, Congress must pass a bill providing physicians and other clinicians with a payment update that takes into account the cost of actually delivering care to patients." The letter, which was dated October 11 and made public on Tuesday, was sent to House Speaker Mike Johnson (R-La.) and House Minority Leader Hakeem Jeffries (D-N.Y.).

The letter noted that the proposed cuts mark the fifth consecutive year that CMS has proposed a cut to the fee schedule. "While Congress has stepped in the past 4 years to pass legislation to mitigate portions of these cuts, the fact remains that the MPFS is inherently broken," the members wrote. "The continued cuts have forced medical groups and integrated systems of care to make difficult choices, such as imposing hiring freezes, delaying system improvements, delaying implementation of care model changes including transitions to value-based care systems, and possibly eliminating services."

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Postoperative Chronic Pain: Experts Urge Better Recognition

Postoperative chronic pain (POCP) is common and is expected to become increasingly prevalent. This type of pain, however, which specifically arises following surgery, independent of any infection or surgical failure, remains poorly understood. Facilities dedicated to treating it are nearly nonexistent.

At the 2024 congress of the French Society of Anesthesia and Resuscitation, anesthesiologists specializing in pain management advocated for improved management of POCP. They put themselves forward as essential interlocutors and actors in this effort. The anesthesiologists also called for better recognition of postoperative pain by patients, general practitioners, and surgeons to enable early intervention and reduce the risk for chronicity.

Underrecognized, Poorly Managed

POCP is defined as persistent pain lasting more than 3 months after surgery, unrelated to preoperative pain, and not associated with surgical complications. It can manifest in various forms, but the most typical scenario involves a patient complaining of persistent pain that developed following a surgical procedure. Normal radiological and biologic assessments rule out infectious complications. The persistence of pain long after surgery contrasts with what is often considered a successful surgical outcome by the surgeon.

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Hackers using 'password spraying' to target healthcare: Report

Iranian hackers are increasingly targeting healthcare organizations, using "brute force" and password spraying attacks to compromise user accounts and gain unauthorized access to sensitive systems. 

Since October 2023, Iranian hackers have intensified their attacks on sectors including healthcare, public health, government, IT, engineering and energy, according to an Oct. 16 press release from the Cybersecurity and Infrastructure Security Agency

The hackers frequently alter multi-factor authentication settings to maintain prolonged access to compromised systems. They also probe the networks to gather more credentials and valuable information that could help them expand their access.

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Pain Medicine Case Reports (PMCR) and Editor-in-Chief Alaa Abd-Elsayed, MD, PhD would like to invite you to submit case reports and case series to the PMCR journal. Your article will be published free of charge.

Open access journals are freely available online for immediate worldwide open access to the full text of published articles. There is no subscription fee for open access journals. Open access journals are no different from traditional subscription-based journals: they undergo the same peer review and quality control as any other scholarly journal.

Interested in becoming a member of the PMCR Editorial Board?

Editorial board members are asked to review 2-6 manuscripts per year. Please submit your most up-to-date CV to sgold@asipp.org for consideration.

For more information or to submit your articles, click here.

CASE REPORT

The Diagnosis of Fentanyl-Induced Chest Wall Rigidity: A Case Report

Christopher McElrath, MD, Ivan Chew, MD, and Thao Lam, BS

Abstract

BACKGROUND: Fentanyl is a widely used opiate drug because of its rapid-acting sedative and analgesic effects. Fentanyl is often used for procedural sedation due to its favorable pharmacokinetics.

CASE REPORT: We report the case of a woman who developed the uncommon complication of fentanyl-induced chest wall rigidity or wooden chest syndrome following the administration of low-dose fentanyl during an elective pain procedure in the absence of commonly described risk factors. Her clinical presentation included total body muscle rigidity along with difficulty with ventilation. Her condition was ultimately reversed with prompt administration of intravenous naloxone.

CONCLUSIONS: Our case reveals that fentanyl-induced chest rigidity is a rare but important adverse event that can potentially occur to any patient. An understanding and awareness of this phenomenon is necessary for all health care providers who may utilize fentanyl for procedural sedation in their practices.

KEY WORDS: Wooden chest syndrome, conscious sedation, fentanyl, ambulatory surgery, chest wall rigidity

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New edition now available!

SYSTEMATIC REVIEW

Comparison of Effectiveness of Intraarticular Hyaluronate and Corticosteroid injections in Adhesive Capsulitis: A Systematic Review and Meta-analysis

Kyeong Eun Uhm, MD, and Min Cheol Chang, MD

Abstract

BACKGROUND: Adhesive capsulitis of the shoulder causes inflammation and adhesions in the shoulder joint capsule, leading to pain and limited range of motion (ROM). Intraarticular corticosteroid (CS) and hyaluronic acid (HA) injections are common therapeutic options for adhesive capsulitis, but their comparative effectiveness remains unclear.

OBJECTIVES: To provide a robust comparison of the outcomes of HA and CS, we conducted a meta-analysis of relevant previous studies that examined the therapeutic effects of intraarticular HA and CS injections in patients with adhesive capsulitis.

STUDY DESIGN: Systematic review and meta-analysis.

METHODS: This meta-analysis of randomized controlled trials compared the effectiveness of intraarticular HA and CS injections. Of the 10,205 articles, 7 met our predetermined criteria and were included in the analysis.

RESULTS: Patients who received CS injections demonstrated superior pain reduction and functional improvement at 2-4 weeks after injection to those who received HA injections. Nevertheless, comparable outcomes were observed between the 2 groups at 6 and 12 weeks. The active or passive range of motion of the shoulder joint was not significantly different between patients who received HA injections and those who received CS injections.

LIMITATIONS: The meta-analysis included only a small number of studies, and the number of HA injections examined in those studies varied from one to 3 at a time, whereas an CS injection was performed only once in most of the included studies.

CONCLUSIONS: The administration of intraarticular HA injection emerges as a commendable therapeutic option for patients with adhesive capsulitis, particularly for those requiring repetitive injections or at risk of developing side effects from injections of CS. Although intraarticular CS injections offer accelerated short-term (2-4 weeks) pain relief and functional improvement, comparable effects were observed within 6 and 12 weeks after intraarticular HA and CS injections.

KEY WORDS: Adhesive capsulitis, shoulder, corticosteroid, hyaluronic acid, pain, function, injection, meta-analysis

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NARRATIVE REVIEW

Treatment Gaps and Emerging Therapies in Lumbar Disc Herniation

Douglas P. Beall, MD, Kee D. Kim, MD, Kevin Macadaeg, MD, Kianoush Donboli, MD, Kinsuk Chauhan, MD, Mohan Sowlay, ., Amy Guo, PhD, and Alexander Vaccaro, MD, PhD

Abstract

BACKGROUND: Lumbar disc herniation (LDH) occurs when the central disc material, primarily the nucleus pulposus, is displaced beyond the outer annulus, compressing the spinal nerve roots. LDH symptoms, including radicular leg pain, radiculopathy, and low back pain, are associated with considerable disease burden and the significant utilization of health care resources.

OBJECTIVES: Provide overview of the current treatment landscape for LDH, identify unmet needs, and describe emerging treatments.

STUDY DESIGN: Narrative literature review.

METHODS: A review of literature concerning available LDH treatments and associated outcomes was conducted in PubMed to identify areas of unmet need. Some key words included “lumbar disc herniation,” “radicular leg pain,” “sciatica,” “treatment,” “therapy,” and “burden.”

RESULTS: For patients who do not respond to conservative therapy, epidural steroid injections (ESIs) are widely used for persistent LDH symptoms. While ESIs provide short-term improvements in radicular pain, evidence that ESIs bestow sustained benefits is limited. ESIs are not approved by the US Food and Drug Administration (FDA) and, in rare cases, carry risks of infection and neurological injury, as well as the potential for long-term systemic effects of glucocorticoids. In cases when nonsurgical treatment fails to relieve symptoms, lumbar discectomy can provide rapid pain relief; however, in addition to the risk of intraoperative complications, the long-term consequences of lumbar discectomy may include recurrent pain or herniation, revision discectomy, loss of disc height, and Modic changes. Treatments for LDH in late-stage clinical development include sustained-release ESI formulations and a novel agent for chemonucleolysis, a nonsurgical method of minimizing the volume of the displaced nucleus pulposus. Emerging minimally invasive therapies that address the underlying pathophysiology of the disease have the potential to bridge the gap between symptomatic treatments and surgery.

LIMITATIONS: Because this paper was a narrative review, literature search and selection processes were not systematic in nature. The evidence regarding the long-term efficacy of some treatments, such as discectomy, was limited by the high rates of crossover between the treatment groups.

CONCLUSIONS: The lack of sustained benefits associated with ESIs and the risks associated with surgery underscore the unmet need for novel, minimally invasive interventional therapies able to address the underlying nerve root compression in LDH.

KEY WORDS: Lumbar disc herniation, radicular leg pain, lumbar radiculopathy, epidural steroid injection, surgery, microdiscectomy, chemonucleolysis, condoliase, intradiscal therapy, minimally invasive treatment

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