scholarly journals FDA Should Re-evaluate mRNA Vaccine Risks and Consider Previously Neglected Evidence

2021 ◽  
Author(s):  
Jianqing Wu
Keyword(s):  
Side Effects ◽  
Review Process ◽  
Relevant Information ◽  
Contextual Knowledge ◽  
Human Beings ◽  
Approval Process ◽  
Critical Problems ◽  
Application Data ◽  
Functional Capacities

After examining both the substantive evidence and approval process used by FDA’s in approving the mRAN vaccines, I showed that due to routine suppression of critical discoveries by leading medical publishers and limitations in FDA’s approval process, FDA could consider only flawed and self-serving findings in context of flawed medical theories in favor of the approval. As reflected in the brief for FDA advisory committee, FDA did not consider fatal flaws in clinical trials, the symptom-based research methods, interference affects of many factors on vaccine benefits/risks, and potential long-term side effects. While off-target expression of mRNA vaccines were known evils in mRNA vaccines, FDA did not consider. It did not address three critical problems responsible for erratic expression: coating variations among mRAN molecules, differences in local hydrodynamic properties in each person, and the massive differences in influencing variables among different persons. By relying on cherry-picked, self-servicing, and deeply flawed application data and flawed contextual knowledge promoted by leading medical publishers, FDA would not see plainly predictable acute personal injuries and expected latent side effects on some people and missed obvious dangers to fetuses, babies, and people with diminished vital functional capacities. Given the fact that the vaccines are imposed on the population, defectiveness of the vaccines can cause the worst catastrophes, FDA must change its review process to overcome biases and suppression practiced by vaccines sponsors and leading medical journals. A workable process must include proactively seeking and considering any relevant information from any source and conducting expanded analysis without being constrained by flawed research models. By using an improved review process, FDA could not have found that mRNA vaccines are effective and safe. I urge FDA to re-valuate mRNA use licenses for the sake of billions of human beings.

Cutaneous ulcers following hydroxyurea therapy

Phlebologie ◽  
2004 ◽  
Vol 33 (06) ◽  
pp. 202-205 ◽  
Author(s):  
K. Hartmann ◽  
S. Nagel ◽  
T. Erichsen ◽  
E. Rabe ◽  
K. H. Grips ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Antineoplastic Agent ◽  
Limited Time ◽  
Myeloproliferative Diseases ◽  
Dermatological Side Effects ◽  
Chronic Myeloproliferative Diseases ◽  
Hydroxyurea Therapy

SummaryHydroxyurea (HU) is usually a well tolerated antineoplastic agent and is commonly used in the treatment of chronic myeloproliferative diseases. Dermatological side effects are frequently seen in patients receiving longterm HU therapy. Cutaneous ulcers have been reported occasionally.We report on four patients with cutaneous ulcers whilst on long-term hydroxyurea therapy for myeloproliferative diseases. In all patients we were able to reduce the dose, or stop HU altogether and their ulcers markedly improved. Our observations suggest that cutaneous ulcers should be considered as possible side effect of long-term HU therapy and healing of the ulcers can be achieved not only by cessation of the HU treatment, but also by reducing the dose of hydroxyurea for a limited time.

Long-term side effects following pneumonectomy: A case report and review of the literature

2019 ◽  
Author(s):  
BA Högerle ◽  
EL Bulut ◽  
L Klotz ◽  
F Eichhorn ◽  
M Eichhorn ◽  
...  
Keyword(s):  
Case Report ◽  
Side Effects ◽  
Review Of The Literature

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Rituximab-Containing Risk-Adapted Treatment Strategy in Nodular Lymphocyte Predominant Hodgkin Lymphoma: 7-Years Follow-Up

Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1760
Author(s):  
Novella Pugliese ◽  
Marco Picardi ◽  
Roberta Della Pepa ◽  
Claudia Giordano ◽  
Francesco Muriano ◽  
...  
Keyword(s):  
Side Effects ◽  
Hodgkin Lymphoma ◽  
Prognostic Score ◽  
Single Agent ◽  
Response To Therapy ◽  
Baseline Risk ◽  
Historical Cohort ◽  
Treatment Groups

Background: Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) is a rare variant of HL that accounts for 5% of all HL cases. The expression of CD20 on neoplastic lymphocytes provides a suitable target for novel treatments based on Rituximab. Due to its rarity, consolidated and widely accepted treatment guidelines are still lacking for this disease. Methods: Between 1 December 2007 and 28 February 2018, sixteen consecutive newly diagnosed adult patients with NLPHL received Rituximab (induction ± maintenance)-based therapy, according to the baseline risk of German Hodgkin Study Group prognostic score system. The treatment efficacy and safety of the Rituximab-group were compared to those of a historical cohort of 12 patients with NLPHL who received Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) chemotherapy followed by radiotherapy (RT), if needed, according to a similar baseline risk. The primary outcome was progression-free survival (PFS) and secondary outcomes were overall survival (OS) and side-effects (according to the Common Terminology Criteria for Adverse Events, v4.03). Results: After a 7-year follow-up (range, 1–11 years), PFS was 100% for patients treated with the Rituximab-containing regimen versus 66% for patients of the historical cohort (p = 0.036). Four patients in the latter group showed insufficient response to therapy. The PFS for early favorable and early unfavorable NLPHLs was similar between treatment groups, while a better PFS was recorded for advanced-stages treated with the Rituximab-containing regimen. The OS was similar for the two treatment groups. Short- and long-term side-effects were more frequently observed in the historical cohort. Grade ≥3 neutropenia was more frequent in the historical cohort compared with the Rituximab-group (58.3% vs. 18.7%, respectively; p = 0.03). Long-term non-hematological toxicities were observed more frequently in the historical cohort. Conclusion: Our results confirm the value of Rituximab in NLPHL therapy and show that Rituximab (single-agent) induction and maintenance in a limited-stage, or Rituximab with ABVD only in the presence of risk factors, give excellent results while sparing cytotoxic agent- and/or RT-related damage. Furthermore, Rituximab inclusion in advanced-stage therapeutic strategy seems to improve PFS compared to conventional chemo-radiotherapy.

Physiological Pacing: A New Road to Future

2021 ◽  
pp. 263246362097804
Author(s):  
Vanita Arora ◽  
Pawan Suri
Keyword(s):  
Side Effects ◽  
Fibrous Tissue ◽  
Cardiac Pacing ◽  
His Bundle ◽  
Anatomy And Physiology ◽  
Long Term Follow Up ◽  
Pacing Lead ◽  
The Right

Anatomy and physiology are the basis of human body functioning and as we have progressed in management of various diseases, we have understood that physiological intervention is always better than an anatomical one. For more than 50 years, a standard approach to permanent cardiac pacing has been an anatomical placement of transvenous pacing lead at the right ventricular apex with a proven benefit of restoring the rhythm. However, the resultant ventricular dyssynchrony on the long-term follow-up in patients requiring more than 40% ventricular pacing led to untoward side effects in the form of heart failure and arrhythmias. To counter such adverse side effects, a need for physiological cardiac pacing wherein the electrical impulse be transmitted directly through the normal conduction system was sought. His bundle pacing (HBP) with an intriguing alternative of left bundle branch pacing (LBBP) is aimed at restoring such physiological activation of ventricles. HBP is safe, efficacious, and feasible; however, localization and placement of a pacing lead at the His bundle is challenging with existing transvenous systems due to its small anatomic size, surrounding fibrous tissue, long-learning curve, and the concern remains about lead dislodgement and progressive electrical block distal to the HBP lead. In this article, we aim to take the reader through the challenging journey of HBP with focus upon the hardware and technique, selective versus nonselective HBP, indications and potential disadvantages, and finally the future prospects.

scholarly journals Cardiooncology—dealing with modern drug treatment, long-term complications, and cancer survivorship

2021 ◽  
Author(s):  
Claudia de Wall ◽  
Johann Bauersachs ◽  
Dominik Berliner
Keyword(s):  
Side Effects ◽  
Checkpoint Inhibitors ◽  
Heart Diseases ◽  
Tumor Therapy ◽  
Treatment Strategies ◽  
Tumor Treatment ◽  
Cardiac Side Effects ◽  
Cardiovascular Side Effects ◽  
Modern Drug

AbstractModern treatment strategies have improved prognosis and survival of patients with malignant diseases. The key components of tumor treatment are conventional chemotherapy, radiotherapy, targeted therapies, and immunotherapy. Cardiovascular side-effects may occur in the early phase of tumor therapy or even decades later. Therefore, knowledge and awareness of acute and long-lasting cardiac side effects of anti-cancer therapies are essential. Cardiotoxicity impairs quality of life and overall survival. The new cardiologic subspecialty ‘cardio-oncology’ deals with the different cardiovascular problems arising from tumor treatment and the relationship between cancer and heart diseases. Early detection and treatment of cardiotoxicity is of crucial importance. A detailed cardiac assessment of patients prior to administration of cardiotoxic agents, during and after treatment should be performed in all patients. The current review focusses on acute and long-term cardiotoxic side effects of classical cytotoxic and selected modern drug treatments such as immune checkpoint inhibitors and discusses strategies for the diagnosis of treatment-related adverse cardiovascular effects in cancer patients.

scholarly journals Clinical differentiation of psychogenic non-epileptic seizure: a practical diagnostic approach

2021 ◽  
Vol 57 (1) ◽  
Author(s):  
I. Putu Eka Widyadharma ◽  
Andreas Soejitno ◽  
D. P. G. Purwa Samatra ◽  
Anna M. G. Sinardja
Keyword(s):  
Epileptic Seizure ◽  
Diagnostic Yield ◽  
Relevant Information ◽  
Seizure Semiology ◽  
Unstructured Search ◽  
Baseline Characteristics ◽  
Antiepileptic Medications ◽  
Eeg Pattern

Abstract Background Psychogenic non-epileptic seizure (PNES) has long been the counterpart of epileptic seizure (ES). Despite ample of evidence differentiating the two, PNES mistakenly diagnosed as ES was still common, resulting in unnecessary exposure to long-term antiepileptic medications and reduced patient’s and caregiver’s quality of life, not to mention the burgeoning financial costs. Objectives In this review, we aimed to elucidate various differences between PNES and epileptic seizure with respect to baseline characteristics, seizure semiology, EEG pattern, and other key hallmark features. Methods An unstructured search was carried out in PubMed, MEDLINE, and EMBASE using keywords pertinent to PNES and ES differentiation. Relevant information was subsequently summarized herein. Results PNES differs significantly with ES in terms of baseline characteristics, prodromal symptoms, seizure semiology, presence of pseudosleep, and other hallmark features (for instance provoking seizure with suggestion). The combined approach, if applied appropriately, can yield high diagnostic yield. Conclusions PNES can be clearly differentiated from ES via careful adherence to a set of valid clinical cues. The summarized clinical hallmarks is highly useful to prevent unnecessary ES diagnosis and treatment with AEDs.

scholarly journals Efficacy and Tolerability of Methotrexate and Methylprednisolone in a Comparative Assessment of the Primary and Long-Term Outcomes in Patients with Pulmonary Sarcoidosis

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1289
Author(s):  
Volodymyr Gavrysyuk ◽  
Ievgenia Merenkova ◽  
Yaroslav Dziublyk ◽  
Nataliia Morska ◽  
Nataliia Pendalchuk ◽  
...  
Keyword(s):  
Side Effects ◽  
Relapse Rate ◽  
Total Duration ◽  
Treatment Resistance ◽  
Pulmonary Sarcoidosis ◽  
Long Term Outcomes ◽  
High Resolution Computed Tomography ◽  
Chi Square ◽  
Ct Data

Background: There is insufficient information in the literature on the comparative efficacy and tolerability of methotrexate (MTX) and methylprednisolone (MP) in patients with pulmonary sarcoidosis in assessing primary outcomes and the relapse rate. Purpose: The aim of our study was to evaluate primary and long-term outcomes of using MTX and MP in patients with pulmonary sarcoidosis. Methods: A total of 143 patients with newly diagnosed pulmonary sarcoidosis, verified by high-resolution computed tomography (CT) data, were examined. Corticosteroid (CS) therapy was used in 97 patients using MP at a dose of 0.4 mg/kg body weight for 4 weeks, followed by a dose reduction to 0.1 mg/kg by the end of the sixth month. The total duration of CS therapy was 12 months on average. Forty-six patients were treated with MTX at a dose of 10 mg/week (28) and 15 mg/week (18) per os for 6 to 12 months. The study of the relapse rate was conducted within 12 months after the CT data normalization in 60 patients after CS therapy and in 24 after MTX treatment. Results: MP treatment was successfully completed in 68 (70.1%), and MTX in 29 (60.4%) patients. In five MP patients (5.2%) and in five (10.9%) MTX, treatment was discontinued due to serious side effects. In seven (7.2%) MP patients and ten (21.7%) MTX patients, treatment required additional therapy due to the lack of efficacy. Progression with MP treatment (17–17.5%) was more common than with MTX (2–4.3%; Chi square = 4.703, p = 0.031). Relapses after MP therapy were observed in 26 (43.3%) patients, and after MTX therapy in 2 (8.3%; Chi square = 9.450, p = 0.003). Conclusion: In patients with pulmonary sarcoidosis, MTX monotherapy does not differ significantly from MP monotherapy in terms of the level of efficacy and the rate of serious side effects. Increasing the MTX dose from 10 to 15 mg/week accelerates the rate of regression of sarcoidosis, improves treatment efficacy, and does not affect the rate of serious side effects. When using MTX, there is a significant decrease in the incidence of treatment resistance and the relapse rate.

scholarly journals ES-1 Clinical results of tumor treating fields in patients with glioblastoma in Japan, compared with global surveillance

2020 ◽  
Vol 2 (Supplement_3) ◽  
pp. ii3-ii3
Author(s):  
Yoshihiro Muragaki ◽  
Masayuki Nitta ◽  
Taiichi Saito ◽  
Shunichi Tutsuki ◽  
Atsushi Fukui ◽  
...  
Keyword(s):  
Side Effects ◽  
Insurance Coverage ◽  
Intermediate Frequency ◽  
Clinical Results ◽  
Tumor Treating Fields ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Us Fda ◽  
Medical University

Abstract INTRODUCTION: The tumor treatment field induces apoptosis of tumor cells by providing a low intensity, intermediate frequency, alternating current electric field via a transducer array. TTFields is based on Phase 3 EF-11 and EF-14 trials for glioblastoma in the US FDA and Japan PMDA. Therefore, I will report the statistics of TTFields use in Japan along with recent papers. METHODS: 410 patients were treated with TTFields in Japan (December 2017-), of which 17 were at Tokyo Women’s Medical University. We also referred to papers about global post-marketing surveillance and recent studies. RESULTS: Of the 410 patients, 409 (99.8%) were diagnosed with ndGBM(male: female, 66.8%: 33.2%). As of June 2020, 222 patients (54.1%) were on treatment and 188 (45.9%) were discontinued. In 17 cases at TWMU, the average age was 46.3 years. The average treatment period was 218 days, with 6 patients (35%) continuing treatment, 6 patients (35%) discontinuing due to patient wishes, and 5 patients (30%) discontinuing treatment due to recurrence. Side effects were contact dermatitis under the array in 9 patients (57%) and mild malaise in 7 patients (43%). We experienced long-term progression-free cases with TTF use of 25 months (survival 30 months after surgery) with a glioma partially resected and 21 months (survival 27 months after surgery) with a biopsied glioma. In the biopsy case, bevacizumab was used in combination during the treatment. Conclusion: In global surveillance, use for rGBM accounts for 39%, but Japan is limited to use for ndGBM due to insurance coverage. In terms of side effects, it showed a good safety profile comparable to previous trials. Long-term progression-free cases have been observed, and it is necessary to examine the characteristics of patients who respond to treatment and the effect of concomitant use with bevacizumab by prospective studies

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