Lawyer Spars With FDA Over J&J Risperdal Court Documents
In an unusual tactic, an attorney is prodding the FDA to seek documents that purportedly detail side effects caused by the Risperdal antipsychotic, but cannot be released publicly due to a court order. The documents were sealed by a Philadelphia judge as part of ongoing litigation over claims the Johnson &Johnson drug causes gynecomastia, which is the abnormal development of breasts in males (back story). For the past year, Stephen Sheller has attempted to convince the FDA that the documents should be disclosed and, initially, filed a Citizen’s Petition, which also asks the agency to require a so-called Black Box warning to reflect what he has termed a lack of safety data. An FDA spokeswoman tells us the agency is “actively reviewing” the petition, but declined to comment further. At issue is a deposition by former FDA commissioner David Kessler, who last fall submitted a 92-page report submitted as part of the litigation and slammed J&J for allegedly promoting Risperdal for unapproved uses (back story). His report - which is publicly available in four parts and can be read here, here, here and here - also refers to other documentation that is under protective order, according to Sheller. In a recent letter to the FDA, Sheller refers to Kessler’s review of a 2003 study in the Journal of Clinical Psychiatry (read the abstract here). Funded by a J&J unit, the meta-analysis...Read more
Background: Androgen receptor (AR) has been described to play a prominent role in male breast cancer (MBC). It maps on chromosome X, and recent reports indicate that X-chromosome polysomy is frequent in MBC. Since the response to anti-androgen therapy may depend on AR polysomy and on its overexpression similarly to prostate cancer, the aim of the present study was to investigate the DNA methylation level of AR and its coregulators, especially those mapped on the X-chromosome, that may influence the activity of AR in MBC.Methods: The DNA methylation level of AR, MAGEA2, MAGEA11, MAGEC1, MAGEC2, FLNA, HDAC6, and UXT, mapped ...
Conditions: Gynecomastia; Thoracic Interfascial Plane Block; Thoracic Paravertebral Block; Anesthesia Interventions: Procedure: Tumescent local anesthesia; Procedure: Thoracic paravertebral block; Procedure: Thoracic interfascial plane block Sponsor: Tanta University Recruiting
To investigate the feasibility of single-port endoscopic mastectomy via the lateral chest approach in the treatment of Simon grade II gynecomastia. Data from 12 patients with grade II gynecomastia admitted from January 2017 to November 2018 were retrospectively analyzed, and related satisfaction surveys were conducted 6 months after the operation. All surgeries were successfully performed under single-port endoscopy, and no patients were converted to open surgery. There were no serious complications related to the surgery, and all the patients were satisfied with the postoperative appearance. The application of single-p...
Publication date: Available online 11 May 2020Source: Academic RadiologyAuthor(s): Mohamad Ali Kazemi, Samira Hemmati, Behnaz Moradi, Hashem Sharifian, Kavous Firooznia, Nasrin Nikravangolsefid
In this study, we describe two male siblings with mild intellectual disability, global developmental delay, short stature, microcephaly, and nyctalopia. Whole exome sequencing of the affected siblings and the parents identified a missense var iant (c.413C > G) in thePHF6 gene, which leads to alteration of a serine residue at position 138 to cysteine. This mutation is located in a highly conserved region. Sanger sequencing confirmed the segregation of this mutation in the family in an X-linked recessive fashion. Multiple mass spectrometry-based proteomic studies have reported phosphorylation at serine 138 ...
We report a case that occurred in the breasts of a 62-year-old man. A clinical diagnosis of gynecomastia was initially made. Partial mastectomy was done and MSL was reported on histopathologic examination. Our literature search revealed no previous case of MSL in the breast reported from our environment.
Background: 47,XXY commonly known as Klinefelter syndrome (KS) is the most common male sex chromosome aneuploidy. The syndrome is characterized by hypotonicity, developmental delays, learning disabilities, and psychosocial problems during infancy/childhood and low testosterone production (hypogonadism) in adolesence/adulthood. Untreated, adolescents and adults may develop gynecomastia, osteoporosis and most commonly, infertility. The current standard of care offers treatment for KS at the onset of puberty for boys following molecular diagnosis.
In conclusion, immunoglobulins exhibit limited benefit on immune ‐neuropathy in patients with coexisting KD.