Article
Engineering, Environmental
Chang-Gui Pan, Svenja M. Mintenig, Paula E. Redondo-Hasselerharm, Paula H. M. W. Neijenhuis, Ke-Fu Yu, Ying-Hui Wang, Albert A. Koelmans
Summary: This study found that the uptake of microplastics by benthic organisms is taxon-specific, but the size distributions are consistent across sediments and taxa. Additionally, the polymer composition of microplastics differed significantly between invertebrates and their host sediment.
ENVIRONMENTAL SCIENCE & TECHNOLOGY
(2021)
Letter
Medicine, General & Internal
Bryan S. Walsh, Ameet Sarpatwari, Benjamin N. Rome, Aaron S. Kesselheim
Summary: This cohort study examined the frequency of first generic drugs with skinny labels being approved in the United States.
JAMA INTERNAL MEDICINE
(2021)
Article
Genetics & Heredity
Tara J. Schmidlen, Sara L. Bristow, Kathryn E. Hatchell, Edward D. Esplin, Robert L. Nussbaum, Eden V. Haverfield
Summary: This study compared the uptake rates of cascade genetic testing under different indications and found that the testing rate was higher among families of diagnostic probands. A personal or family history of disease may be a contributing factor to the higher testing rate.
FRONTIERS IN GENETICS
(2022)
Article
Oncology
Amy A. Lo, Andrew Wallace, Daniel Oreper, Nicolas Lounsbury, Charles Havnar, Ximo Pechuan-Jorge, Thomas D. Wu, Richard Bourgon, Ryan Jones, Katrina Krogh, Guang-Yu Yang, Oliver A. Zill
Summary: The distribution of clonal neoantigens varies across different cancer types, and factors influencing neoantigen targeting include tumor type, multilesion sampling, neoantigen expression, and HLA allele retention. Prioritizing mutations with higher purity-adjusted and ploidy-adjusted variant allele frequency enriches for globally clonal neoantigens.
JOURNAL FOR IMMUNOTHERAPY OF CANCER
(2021)
Article
Oncology
You-Zhu Wei, Zhi-Bin Cai, Chen-Long Zhu, Yan-Ming Zhou, Xiao-Feng Zhang
Summary: The study evaluated the long-term survival outcomes of patients with duodenal GIST who underwent radical resection (RR) or limited resection (LR). Results showed that surgical modalities did not have a significant impact on long-term survival outcomes, which should mainly depend on tumor size and location.
ANNALS OF SURGICAL ONCOLOGY
(2021)
Article
Oncology
Joseph M. M. Unger, Michael LeBlanc, Suzanne George, Norman Wolmark, Walter J. J. Curran Jr, Peter J. J. O'Dwyer, Mitchell D. D. Schnall, Robert S. S. Mannel, Sumithra J. J. Mandrekar, Robert J. J. Gray, Fengmin Zhao, Mariama Bah, Riha Vaidya, Charles D. D. Blanke
Summary: The National Cancer Institute National Cancer Clinical Trials Network (NCTN) groups in the United States have conducted publicly funded oncology research for 50 years, but the combined impact of all adult network group trials has never been systematically examined.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Immunology
Deepak Goni, Arihant Jain, Charanpreet Singh, Nishant Jindal, Ram Nampoothiri, Aditya Jandial, Deepesh Lad, Alka Khadwal, Gaurav Prakash, Shano Naseem, Neelam Varma, Pankaj Malhotra
Summary: This study aimed to determine the feasibility and efficacy of treatment-free remission (TFR) with generic imatinib in patients with Chronic Myeloid Leukaemia-Chronic phase (CML-CP). The results showed that approximately 42.3% of patients in sustained deep molecular response were able to maintain TFR. Therefore, this study suggests that generic imatinib can be safely discontinued after achieving deep molecular remission in CML-CP patients.
INDIAN JOURNAL OF MEDICAL RESEARCH
(2023)
Article
Endocrinology & Metabolism
Diana Kindler, Cinzia Maschio, Ruiqing Ni, Valerio Zerbi, Daniel Razansky, Jan Klohs
Summary: The study found no significant differences in regional cerebral blood flow between P301L mice and non-transgenic littermates at different disease stages, indicating that hypoperfusion and neurodegeneration are not phenotypes of P301L mice. Additional research is needed to further understand the relationship between tau, neurodegeneration, vascular dysfunction, and modulators in Alzheimer's disease and primary tauopathies.
JOURNAL OF CEREBRAL BLOOD FLOW AND METABOLISM
(2022)
Review
Hematology
Abdulkadir Ercaliskan, Duygu Seyhan Erdogan, Ahmet Emre Eskazan
Summary: The introduction of generic imatinib has significantly reduced healthcare costs for CML patients. Most studies indicate that generics are comparable in efficacy and safety to the original molecule, but there are also conflicting results in some studies. Despite the generally positive outcomes of generics globally, further time and research may be needed to draw conclusive long-term conclusions.
Article
Chemistry, Multidisciplinary
Soumya Jyoti Singha Roy, Conor Loynd, Delilah Jewel, Sarah E. Canarelli, Elise D. Ficaretta, Quan A. Pham, Eranthie Weerapana, Abhishek Chatterjee
Summary: We have developed a novel visible-light-catalyzed bioconjugation reaction, PhotoCLIC, for selective modification of 5-hydroxytryptophan residue (5HTP) on full-length proteins. This reaction enables rapid and site-specific protein bioconjugation using catalytic amounts of methylene blue and blue/red light-emitting diodes. The PhotoCLIC product has a unique structure likely formed through singlet oxygen-dependent modification of 5HTP. PhotoCLIC has a wide substrate scope and is compatible with strain-promoted azide-alkyne click reaction, allowing for site-specific dual-labeling of a target protein.
ANGEWANDTE CHEMIE-INTERNATIONAL EDITION
(2023)
Article
Biochemical Research Methods
Aparna Biswas, Yu-Fong Peng, Vikas Kaushik, Sofia Origanti
Summary: The Shwachman-Diamond syndrome (SDS) is a rare genetic disorder caused by mutations in the SBDS gene. SBDS is a ribosomal maturation factor that is crucial for the release of eIF6 during the late stages of ribosomal subunit maturation. Researchers have successfully labeled specific domains of SBDS with a fluorescent marker to study their dynamics upon binding to 60S and assess the effects of SDS-specific mutations.
Article
Medicine, General & Internal
Gordon D. Schiff, Mayya Volodarskaya, Elise Ruan, Andrea Lim, Adam Wright, Hardeep Singh, Harry Reyes Nieva
Summary: This study identified and collected recurring diagnostic pitfalls from cases of diagnostic errors. Clinicians could benefit from understanding both disease-specific and generic diagnostic pitfalls. The findings of this study may inform educational and quality improvement efforts to anticipate and prevent future errors.
Article
Chemistry, Multidisciplinary
Yanan Li, Menghuan Li, Li Liu, Chencheng Xue, Yang Fei, Xuan Wang, Yuchen Zhang, Kaiyong Cai, Yanli Zhao, Zhong Luo
Summary: This study reports a combinational strategy based on clinically tested constituents to selectively induce ferroptosis in metabolically reprogrammed tumor cells, providing a generally applicable therapy.
Review
Biochemistry & Molecular Biology
Barry S. Cooperman
Summary: The introduction of fluorophores into RNA for both in vitro and in cellulo studies of RNA function and cellular distribution is a subject of great current interest. Various methods for site-specific fluorescent labeling of RNAs are reviewed, including the utilization of natural posttranslational modifications, enzymatic transferase reactions, nucleic acid-assisted labeling, and de novo preparation of specifically labeled RNAs.
Article
Orthopedics
Ittai Shichman, Mark Kurapatti, Mackenzie Roof, Thomas H. Christensen, Joshua C. Rozell, Ran Schwarzkopf
Summary: This study investigates the impact of the indication for revision total hip arthroplasty (rTHA) on costs and postoperative outcomes. The findings demonstrate variations in surgical factors, length of stay, and costs between different indications. Therefore, patients with different indications may require tailored perioperative management and cost-reducing measures.
JOURNAL OF ARTHROPLASTY
(2022)
Article
Pharmacology & Pharmacy
Kimberly Feng, Aaron S. Kesselheim, Massimiliano Russo, Benjamin N. Rome
Summary: The availability of biosimilar drugs did not significantly reduce out-of-pocket costs for patients, despite competition with the reference biologic. While the percentage of claims with out-of-pocket costs decreased after biosimilar competition, the average costs for these claims actually increased.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Economics
Benjamin N. Rome, Alexander C. Egilman, Neeraj G. Patel, Aaron S. Kesselheim
Summary: Brand-name drug manufacturers can market or license authorized generics (AGs), which are the same product sold under a generic name. By contrast, independent generics (IGs) are made by other manufacturers. We used this case study to understand how AGs can affect the length of brand-name exclusivity and robustness of generic competition.
Editorial Material
Medicine, General & Internal
Cristina Richie, Aaron S. Kesselheim, David S. Jones
Editorial Material
Medicine, General & Internal
Kerstin N. Vokinger, Jerry Avorn, Aaron S. Kesselheim
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Article
Critical Care Medicine
Brandon J. Demkowicz, S. Sean Tu, Aaron S. Kesselheim, Michael A. Carrier, William B. Feldman
Summary: Pharmaceutical companies rely on device patents to maintain market exclusivity for brand-name inhalers.
Article
Pharmacology & Pharmacy
Sanket S. Dhruva, Aaron S. Kesselheim, Steven Woloshin, Robin Z. Ji, Zhigang Lu, Jonathan J. Darrow, Rita F. Redberg
Summary: In June 2021, the FDA granted accelerated approval to aducanumab for Alzheimer's disease, which was controversial due to concerns about its basis and lack of clinical benefit. A survey of physicians revealed that a majority of them would not prescribe or recommend aducanumab and reported losing trust in other drugs approved through the accelerated approval program. With more Alzheimer's disease treatments on the horizon, the survey findings shed light on how the FDA's regulatory decisions impact physicians' perspectives and prescribing behavior.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Health Care Sciences & Services
Benjamin N. Rome, Simon J. Gunter, Aaron S. Kesselheim
Summary: Objective: This study investigated the utilization and timing of authorized generics (AGs) in the market. Results showed that AGs accounted for 4% of Medicaid prescription drug use from 2014 to 2020 and represented a significant market share when available. Among AGs without generic competition before 2014, 35% were introduced at least 1 year before independent generics or had no independent generic competition through December 2020. The findings suggest potential strategies by manufacturers to impact brand-name drug prices and independent generic competition through AGs.
HEALTH SERVICES RESEARCH
(2023)
Article
Medicine, General & Internal
Hussain S. Lalani, Sarosh Nagar, Ameet Sarpatwari, Rachel E. Barenie, Jerry Avorn, Benjamin N. Rome, Aaron S. Kesselheim
Summary: This retrospective cohort study aimed to estimate US public investment in the development of mRNA covid-19 vaccines. The study analyzed publicly funded science from January 1985 to March 2022 and identified 34 NIH-funded research grants directly related to mRNA covid-19 vaccines. The total US public investment in research, development, production, and purchase of mRNA covid-19 vaccines was at least $31.9bn.
BMJ-BRITISH MEDICAL JOURNAL
(2023)
Review
Medicine, General & Internal
Beatrice L. Brown, Aaron S. Kesselheim, Ameet Sarpatwari
Summary: In this analysis, the authors, Ameet Sarpatwari, Beatrice Brown, and Aaron Kesselheim, examine the differences in primary and secondary prevention measures for teratogenic drugs.
Editorial Material
Rheumatology
Benjamin N. N. Rome, Aaron S. S. Kesselheim
ARTHRITIS & RHEUMATOLOGY
(2023)
Article
Medicine, General & Internal
Catherine S. Hwang, Aaron S. Kesselheim, Ameet Sarpatwari, Krista F. Huybrechts, Gregory Brill, Benjamin N. Rome
Summary: This study estimated the impact of the COVID-19 pandemic and regulatory changes on abortion rates. The findings showed a decrease in the incidence rate of procedural abortions during the pandemic, and this lower rate persisted even after other elective procedures returned to pre-pandemic levels. The use of telehealth for insurance-covered medical abortions remained rare despite the removal of the in-person dispensing requirement for mifepristone.
ANNALS OF INTERNAL MEDICINE
(2023)
Article
Medicine, General & Internal
Liam Bendicksen, Diana M. Zuckerman, Jerry Avorn, Sophia Phillips, Aaron S. Kesselheim
Summary: The FDA approved eteplirsen for Duchenne muscular dystrophy in 2016 based on a study of 12 boys. The approval has been controversial due to questionable evidence, delays in testing, and high prices. Questions about effectiveness and safety remain, and further reforms are needed to balance evidence generation with patient safety.
ANNALS OF INTERNAL MEDICINE
(2023)
Editorial Material
Pharmacology & Pharmacy
S. Sean Tu, Aaron S. Kesselheim
Summary: This article discusses the barriers that patents create for generic drug entry and introduces the "skinny label" pathway created by Congress to address this issue. The recent court case has put this pathway at risk.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Editorial Material
Medicine, General & Internal
Matthew Vogel, Aaron S. Kesselheim, William B. Feldman, Benjamin N. Rome
Summary: Delaying the launch of new medications to negotiate prices with Medicare is rarely a financially sensible strategy for drug companies.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Review
Hematology
Gemma Reynolds, Edward R. Scheffer Cliff, Ghulam Rehman Mohyuddin, Rakesh Popat, Shonali Midha, Melissa Ng Liet Hing, Simon J. Harrison, Aaron S. Kesselheim, Benjamin W. Teh
Summary: Bispecific antibodies, a novel immunotherapy with promising efficacy against multiple myeloma, may increase the risk of infections, especially when targeting BCMA and used in combination with other agents. Vigilant infection screening and prophylaxis strategies are necessary.