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9. Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997–2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR)

Author

Bennett, Charles L., Hoque, Shamia, Olivieri, Nancy, Taylor, Matthew A., Aboulafia, David, Lubaczewski, Courtney, Bennett, Andrew C., Vemula, Jay, Schooley, Benjamin, Witherspoon, Bartlett J., Godwin, Ashley C, Ray, Paul S., Yarnold, Paul R., Ausdenmoore, Henry C., Fishman, Marc, Herring, Georgne, Ventrone, Anne, Aldaco, Juan, Hrushesky, William J., Restaino, John, Thomsen, Henrik S., Marx, Robert, Migliorati, Cesar, Ruggiero, Salvatore, Nabhan, Chadi, Carson, Kenneth R., McKoy, June M., Yang, Y. Tony, Schoen, Martin W., Knopf, Kevin, Martin, Linda, Sartor, Oliver, Rosen, Steven, and Smith, William K.

Published
2021
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12. A SONAR report on Nirmatrelvir/ritonavir-associated rebound COVID-19: Using new databases for evaluating new diseases.

Author

Bennett, Charles L., Magagnoli, Joseph, Gundabolu, Krishna, Georgantopoulos, Peter, Lebby, Akida, Watson, Gretchen, Knopf, Kevin, Martin, Linda, Carson, Kenneth R., Hrushesky, William J., Nabhan, Chadi, Zyszkowski, Edward, Smith, Edward B., Gale, Robert Peter, and Rosen, Steven T.

Subjects
COVID-19 pandemic, VACCINATION status, COVID-19, COVID-19 testing, DATABASES, SOCIAL media, TONOMETERS
Abstract

Introduction: In May 2022, the Centers for Disease Control and Prevention disseminated an alert advising that "a few" persons with Nirmatrelvir/ritonavir (NM/R)-associated rebound of COVID-19 infection had been identified. Three case reports appearing as pre-print postings described the first cases. Analyses in March 2023 by NM/R's manufacturer and the Food and Drug Administration (FDA) reported no association between NM/R and COVID-19 rebound in a large phase 3 randomized clinical trial. Our study evaluated if social media databases or electronically disseminated new articles might provide insights related to the putative new toxicity, NM/R-associated COVID-19 rebound. Methods: Information on NM/R-associated COVID-19 rebound cases was abstracted from preprint postings of non-peer-reviewed manuscripts, social media websites, electronically disseminated print and television media reports, a new FDA adverse event database for drugs that received Emergency Use Approval, and news articles in scientific journals. Results: Thirty-five persons experienced presumed or documented NM/R-associated COVID-19 rebound, based on information described in preprint services (n = 27), Twitter postings and related news articles (n = 7), and news articles without related Twitter reports (n = 1). These reports included information on dates of initial COVID-19 illness and rebound onset, COVID-19 testing, vaccine status, presentation, and outcome. A new FDA safety database identified 12,500 possible cases of this toxicity, but the quality of these data was poor. Preprint postings preceded peer-reviewed publications describing the same cases by four months. Social media websites including Instagram, Reddit, YouTube, the Center for Disease Control and Prevention's (CDC) Health Alert Network, CDC Twitter, and Facebook did not provide clinically meaningful information on individual cases. Conclusion: Preprint services and Twitter facilitated identification of the largest case series of NM/R-associated COVID-19 rebound. The cases were reported in non-peer-reviewed media several weeks prior to the first peer-reviewed electronically disseminated publication of one person with this diagnosis. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Congressional Investigation of RevAssist-Linked and General Pricing Strategies for Lenalidomide.

Author

Bennett, Charles L., Gibbons, Jason B., Trujillo, Antonio, Carson, Kenneth R., Knopf, Kevin, Nabhan, Chadi, Rosen, Steven T., and Aboulafia, David M.

Subjects
HEALTH services accessibility, POLICY sciences, PATIENT safety, COST analysis, CARBOCYCLIC acids, COMMUNICATION, PATENTS, GENERIC drugs, MEDICAL care costs
Abstract

The article reports on the investigation by the U.S. Congress on the pricing and market protection by drug makers of anti-multiple myeloma agent lenalidomide. Topics mentioned include the impact of the tactics used by drug makers on patients and Medicare, the use of risk evaluation and mitigation strategy, called RevAssist, to prevent generic competition and the factors that influenced the pricing activity of lenalidomide.

Published
2024
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16. Clinical and Genomic Characteristics of Small Cell Lung Cancer in Never Smokers: Results From a Retrospective Multicenter Cohort Study

Author

Thomas, Anish, Mian, Idrees, Tlemsani, Camille, Pongor, Lorinc, Takahashi, Nobuyuki, Maignan, Kathleen, Snider, Jeremy, Li, Gerald, Frampton, Garrett, Ali, Siraj, Kim, Sehyun, Nichols, Samantha, Rajapakse, Vinodh, Guha, Udayan, Sharon, Elad, Fujimoto, Junya, Moran, Cesar A., Wistuba, Ignacio I., Wei, Jun S., Khan, Javed, Szabo, Eva, Torres, Aracelis Z., and Carson, Kenneth R.

Published
2020
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20. Analysis of Peripheral T-cell Lymphoma Diagnostic Workup in the United States

Author

Hsi, Eric D., Horwitz, Steven M., Carson, Kenneth R., Pinter-Brown, Lauren C., Rosen, Steven T., Pro, Barbara, Federico, Massimo, Gisselbrecht, Christian, Schwartz, Marc, Bellm, Lisa A., Acosta, Mark, Collie, Angela M., Gruver, Aaron M., Grzywacz, Bartosz J., Turakhia, Samir, Shustov, Andrei R., Advani, Ranjana H., Feldman, Tatyana, Lechowicz, Mary Jo, Smith, Sonali M., Lansigan, Frederick, Tulpule, Anil, Craig, Michael D., Greer, John P., Kahl, Brad S., Leach, Joseph W., Morganstein, Neil, Casulo, Carla, Park, Steven I., and Foss, Francine M.

Published
2017
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25. Lymphoma Surveillance Counterpoint: USA

Author

Carson, Kenneth R., Bartlett, Nancy L., Johnson, Frank E., editor, Maehara, Yoshihiko, editor, Browman, George P., editor, Margenthaler, Julie A., editor, Audisio, Riccardo A., editor, Thompson, John F., editor, Johnson, David Y., editor, Earle, Craig C., editor, and Virgo, Katherine S., editor

Published
2013
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26. Five hematologic tests and treatments to question

Author

Hicks, Lisa K., Bering, Harriet, Carson, Kenneth R., Haynes, Adam E., Kleinerman, Judith, Kukreti, Vishal, Ma, Alice, Mueller, Brigitta U., O’Brien, Sarah H., Panepinto, Julie A., Pasquini, Marcelo C., Rajasekhar, Anita, Sarode, Ravi, and Wood, William A.

Published
2014
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28. Characteristics and clinical outcomes of patients with ALK‐positive anaplastic large cell lymphoma: Report from the prospective international T‐cell lymphoma project

Author

Chiattone, Carlos, primary, Civallero, Monica, additional, Fischer, Thais, additional, Miranda, Eliana, additional, Manni, Martina, additional, Zing, Natalia P. C., additional, Pileri, Stefano A., additional, Montoto, Silvia, additional, Horwitz, Steven M., additional, Cabrera, Maria Elena, additional, De Souza, Carmino A., additional, Nagler, Arnon, additional, Luminari, Stefano, additional, Ferreri, Andrés J. M., additional, Carson, Kenneth R., additional, Re, Alessandro, additional, Rigacci, Luigi, additional, Nassi, Luca, additional, Stepanishyna, Yana, additional, Federico, Massimo, additional, and Inghirami, Giorgio, additional

Published
2022
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29. Survival of veterans treated with enzalutamide and abiraterone for metastatic castrate resistant prostate cancer based on comorbid diseases

Author

Schoen, Martin W., primary, Carson, Kenneth R., additional, Eisen, Seth A., additional, Bennett, Charles L., additional, Luo, Suhong, additional, Reimers, Melissa A., additional, Knoche, Eric M., additional, Whitmer, Alison L., additional, Yan, Yan, additional, Drake, Bettina F., additional, and Sanfilippo, Kristen M., additional

Published
2022
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32. The 2011–2016 Transdisciplinary Research on Energetics and Cancer (TREC) Initiative: Rationale and Design

Author

Patterson, Ruth E., Colditz, Graham A., Hu, Frank B., Schmitz, Kathryn H., Ahima, Rexford S., Brownson, Ross C., Carson, Kenneth R., Chavarro, Jorge E., Chodosh, Lewis A., Gehlert, Sarah, Gill, Jeff, Glanz, Karen, Haire-Joshu, Debra, Herbst, Karen Louise, Hoehner, Christine M., Hovmand, Peter S., Irwin, Melinda L., Jacobs, Linda A., James, Aimee S., Jones, Lee W., Kerr, Jacqueline, Kibel, Adam S., King, Irena B., Ligibel, Jennifer A., Meyerhardt, Jeffrey A., Natarajan, Loki, Neuhouser, Marian L., Olefsky, Jerrold M., Proctor, Enola K., Redline, Susan, Rock, Cheryl L., Rosner, Bernard, Sarwer, David B., Schwartz, J. Sanford, Sears, Dorothy D., Sesso, Howard D., Stampfer, Meir J., Subramanian, S. V., Taveras, Elsie M., Tchou, Julia, Thompson, Beti, Troxel, Andrea B., Wessling-Resnick, Marianne, Wolin, Kathleen Y., and Thornquist, Mark D.

Published
2013

37. A phase II study of cyclophosphamide, etoposide, vincristine and prednisone (CEOP) Alternating with Pralatrexate (P) as front line therapy for patients with peripheral T-cell lymphoma (PTCL): final results from the T- cell consortium trial

Author

Advani, Ranjana H., Ansell, Stephen M., Lechowicz, Mary J., Beaven, Anne W., Loberiza, Fausto, Carson, Kenneth R., Evens, Andrew M., Foss, Francine, Horwitz, Steven, Pro, Barbara, Pinter-Brown, Lauren C., Smith, Sonali M., Shustov, Andrei R., Savage, Kerry J., and Vose, Julie M.

Published
2016
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39. Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men

Author

Kraus, Albert L., primary, Yu‐Kite, Michelle, additional, Mardekian, Jack, additional, Cotter, Matthew J., additional, Kim, Sindy, additional, Decembrino, Jaclyn, additional, Snow, Tamara, additional, Carson, Kenneth R., additional, Motyl Rockland, Jillian, additional, Gossai, Anala, additional, Wilner, Keith, additional, Wang, Diane D., additional, Huang Bartlett, Cynthia, additional, Oharu, Norihiko, additional, Schnell, Patrick, additional, VanArsdale, Todd, additional, Lu, Dongrui R., additional, and Tursi, Jennifer M., additional

Published
2021
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40. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project

Author

Carson, Kenneth R., Evens, Andrew M., Richey, Elizabeth A., Habermann, Thomas M., Focosi, Daniele, Seymour, John F., Laubach, Jacob, Bawn, Susie D., Gordon, Leo I., Winter, Jane N., Furman, Richard R., Vose, Julie M., Zelenetz, Andrew D., Mamtani, Ronac, Raisch, Dennis W., Dorshimer, Gary W., Rosen, Steven T., Muro, Kenji, Gottardi-Littell, Numa R., Talley, Robert L., Sartor, Oliver, Green, David, Major, Eugene O., and Bennett, Charles L.

Published
2009
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42. Characteristics and Outcome of Extranodal NK/T-cell Lymphoma in North America: A Retrospective Multi-Institutional Experience

Author

Bennani, Nora N., primary, Tun, Aung M., additional, Carson, Kenneth R, additional, Geiger, Jessica L, additional, Maeda, Lauren S, additional, Savage, Kerry J, additional, Rose, Jim, additional, Pinter-Brown, Lauren, additional, Lunning, Matthew A, additional, Abramson, Jeremy S, additional, Bartlett, Nancy L, additional, Vose, Julie M, additional, Evens, Andrew M, additional, Smith, Sonali M, additional, Horwitz, Steven M, additional, Ansell, Stephen M., additional, and Advani, Ranjana H, additional

Published
2021
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43. Mogamulizumab-associated rash frequently mimics cutaneous T-cell lymphoma recurrence but heralds a positive response to therapy: an updated single-center case series

Author

Trum, Nicholas A., primary, Zain, Jasmine, additional, Martinez, Xochiquetzal U., additional, Parekh, VIshwas, additional, Afkhami, Michelle, additional, Abdulla, Farah, additional, Carson, Kenneth R., additional, Rosen, Steven T., additional, Bennett, Charles L., additional, and Querfeld, Christiane, additional

Published
2021
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47. Progressive multifocal leukoencephalopathy associated with brentuximab vedotin therapy: A report of 5 cases from the Southern Network on Adverse Reactions (SONAR) project

Author

Carson, Kenneth R., Newsome, Scott D., Kim, Ellen J., Wagner-Johnston, Nina D., von Geldern, Gloria, Moskowitz, Craig H., Moskowitz, Alison J., Rook, Alain H., Jalan, Pankaj, Loren, Alison W., Landsburg, Daniel, Coyne, Thomas, Tsai, Donald, Raisch, Dennis W., Norris, LeAnn B., Bookstaver, Brandon P., Sartor, Oliver, and Bennett, Charles L.

Published
2014
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48. Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997–2019):A qualitative analysis from the Southern Network on Adverse Reactions (SONAR)

Author

Bennett, Charles L., Hoque, Shamia, Olivieri, Nancy, Taylor, Matthew A., Aboulafia, David, Lubaczewski, Courtney, Bennett, Andrew C., Vemula, Jay, Schooley, Benjamin, Witherspoon, Bartlett J., Godwin, Ashley C., Ray, Paul S., Yarnold, Paul R., Ausdenmoore, Henry C., Fishman, Marc, Herring, Georgne, Ventrone, Anne, Aldaco, Juan, Hrushesky, William J., Restaino, John, Thomsen, Henrik S., Marx, Robert, Migliorati, Cesar, Ruggiero, Salvatore, Nabhan, Chadi, Carson, Kenneth R., McKoy, June M., Yang, Y. Tony, Schoen, Martin W., Knopf, Kevin, Martin, Linda, Sartor, Oliver, Rosen, Steven, Smith, William K., Bennett, Charles L., Hoque, Shamia, Olivieri, Nancy, Taylor, Matthew A., Aboulafia, David, Lubaczewski, Courtney, Bennett, Andrew C., Vemula, Jay, Schooley, Benjamin, Witherspoon, Bartlett J., Godwin, Ashley C., Ray, Paul S., Yarnold, Paul R., Ausdenmoore, Henry C., Fishman, Marc, Herring, Georgne, Ventrone, Anne, Aldaco, Juan, Hrushesky, William J., Restaino, John, Thomsen, Henrik S., Marx, Robert, Migliorati, Cesar, Ruggiero, Salvatore, Nabhan, Chadi, Carson, Kenneth R., McKoy, June M., Yang, Y. Tony, Schoen, Martin W., Knopf, Kevin, Martin, Linda, Sartor, Oliver, Rosen, Steven, and Smith, William K.

Abstract

Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting. Methods: We reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings. Findings: Twenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards (p<0.0018). Manufacturers of four drugs paid $1.7 billion total in criminal fines for failing to inform the FDA and physicians about very serious ADRs. Following FDA approval, the median time to ADR reporting was 7.5 years (Interquartile range 3,13 years). Twelve drugs received Box warnings and one drug received a warning (median, 7.5 years following ADR reporting (IQR 5,11 years). Six

Published
2021

49. The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy‐Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

Author

Bennett, Charles L., primary, Nagai, Sumimasa, additional, Bennett, Andrew C., additional, Hoque, Shamia, additional, Nabhan, Chadi, additional, Schoen, Martin W., additional, Hrushesky, William J., additional, Luminari, Stefano, additional, Ray, Paul, additional, Yarnold, Paul R., additional, Witherspoon, Bart, additional, Riente, Josh, additional, Bobolts, Laura, additional, Brusk, John, additional, Tombleson, Rebecca, additional, Knopf, Kevin, additional, Fishman, Marc, additional, Yang, Y. Tony, additional, Carson, Kenneth R., additional, Djulbegovic, Benjamin, additional, Restaino, John, additional, Armitage, James O., additional, and Sartor, Oliver A., additional

Published
2021
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50. The research on Adverse Drug Events and Reports (RADAR) project

Author

Bennett, Charles L., Samore, Matthew H., Belknap, Steven M., Davidson, Charles J., West, Dennis P., Nebeker, Jonathan R., Lyons, E. Allison, Feldman, Marc D., McKoy, June M., Carson, Kenneth R., Trifilo, Steven M., Schumock, Glen T., Yarnold, Paul R., Evens, Andrew M., Kuzel, Timothy M., Parada, Jorge P., Cournoyer, Denis, Sartor, Oliver, Tallman, Martin S., and Raisch, Dennis W.

Subjects
Company business management, United States. Food and Drug Administration -- Management, Drugs -- Adverse and side effects, Drugs -- Reports, Drugs -- Research
Abstract

A study was conducted to evaluate the structure, operations, and preliminary findings from the Research on Adverse Drug events And Reports (RADAR) project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration. The result showed that a new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance and improve patients safety.

Published
2005

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