While pharmaceutical industry involvement in producing, interpreting, and regulating medical knowledge and practice is widely accepted and believed to promote medical innovation, industry-favouring biases may result in prioritizing corporate profit above public health. Using diabetes as our example, we review successive changes over forty years in screening, diagnosis, and treatment guidelines for type 2 diabetes and prediabetes, which have dramatically expanded the population prescribed diabetes drugs, generating a billion-dollar market. We argue that these guideline recommendations have emerged under pervasive industry influence and persisted, despite weak evidence for their health benefits and indications of serious adverse effects associated with many of the drugs they recommend. We consider pharmaceutical industry conflicts of interest in some of the research and publications supporting these revisions, and in related standard-setting committees and oversight panels. We raise concern over the long-term impact of these multifaceted involvements. Rather than accept industry conflicts of interest as normal, needing only to be monitored and managed, we suggest challenging that normalcy, and ask: what are the real costs of tolerating such industry participation? We urge the development of a broader focus to fully understand and curtail the systemic nature of industry's influence over medical knowledge and practice.
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http://dx.doi.org/10.1007/s11673-021-10119-x | DOI Listing |
J Pharm Biomed Anal
January 2025
State Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China; Simcere Zaiming Pharmaceutical Co, Ltd., Nanjing, China. Electronic address:
Capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) is widely used in the biopharmaceutical industry for monitoring purity and analyzing impurities. The accuracy of the method may be compromised by artificial species resulting from sample preparation or electrophoresis separation due to suboptimal conditions. During non-reduced CE-SDS analysis of a multispecific antibody (msAb), named as multispecific antibody C (msAb-C), a cluster of unexpected peaks was observed after the main peak.
View Article and Find Full Text PDFClin Pharmacokinet
January 2025
College of Pharmacy, Kyungsung University, 309, Suyeong-ro, Nam-gu, Busan, 48434, Republic of Korea.
Background And Objective: Telmisartan exhibits significant pharmacokinetic (PK) variability, but it remains unclear whether its PK profile is altered in hypertensive patients. This study aimed to characterize telmisartan PKs by conducting a meta-analysis and developing a pooled population PK model based on data from healthy subjects and hypertensive patients.
Methods: Relevant literature was identified by a systematic approach.
J Mater Chem B
January 2025
Department of General Surgery, Heilongjiang Provincial Hospital, Harbin, China.
There has been considerable interest in the recent advances in synthetic micro/nanomotors in diverse biofluids due to their potential biomedical applications. However, the propulsion of existing micro/nanomotor platforms for delivery in the gastrointestinal (GI) tract is inefficient. Herein, we present a magnetically and chemically actuated micromotor-tableted pill that can be actively retained in the GI tract .
View Article and Find Full Text PDFClin Transl Sci
January 2025
School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, Republic of Korea.
This study investigated the success rate of Phase 1 clinical trial entry and the factors influencing it in oncology projects involving academia-industry collaboration during the discovery and preclinical stages. A total of 344 oncology projects in the discovery stage and 360 in the preclinical stage, initiated through collaborations with universities or hospitals between 2015 and 2019, were analyzed. The Phase 1 clinical trial entry success rates for oncology collaborative projects were 9.
View Article and Find Full Text PDFClin Transl Sci
January 2025
College of Pharmacy, Daegu Catholic University, Gyeongsan, Korea.
Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates.
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