A judicial trial in which a pharmaceutical company and a former employee were prosecuted for violation of the Pharmaceutical Affairs Act： the pharmaceutical company and former employees have published papers in academic journals by providing researchers with fake data, such as providing false data disguised as having therapeutic effects on the results of multicenter clinical trials for hypertensive drugs.Regarding the case, the Tokyo District Court decision on March 16, 2017, and the Tokyo High Court of Appeals decision on November 19, 2020 indicated that both the pharmaceutical company and its former employees were not guilty. The reason is that the Pharmaceutical Affairs Law is a provision that punishes only when false or exaggerated articles are written for advertising purposes, so publication of scientific papers does not apply.However, there is a question about the interpretation that the provisions of the Pharmaceutical Affairs Law are limited to advertising purposes, and there is room to be identified as advertising purposes from the publication process of the academic dissertation in this case, so I can't agree with the judgment.

A 75-year-old man was admitted to our hospital with sudden onset of vomiting and abdominal distension. The patient was taking medication for arrhythmia. Computed tomography showed stenosis of the ileum and a small bowel dilatation on the oral side from the region of stenosis. A transnasal ileus tube was placed. Enteroclysis using contrast medium revealed an approximately 6-cm afferent tubular stenosis 10 cm from the terminal ileum and thumbprinting in the proximal bowel. Transanal double-balloon enteroscopy showed a circumferential shallow ulcer with a smooth margin and edema of the surrounding mucosa. The stenosis was so extensive that we could not perform endoscopic balloon dilation therapy. During hospitalization, the patient's nutritional status deteriorated. In response, we surgically resected the region of stenosis. Histologic examination revealed disappearance of the mucosal layer and transmural ulceration with marked fibrosis, especially in the submucosal layer. Hemosiderin staining revealed sideroferous cells in the submucosal layers. Based on the pathologic findings, the patient was diagnosed with ischemic enteritis. The patient's postoperative course was uneventful.
Aged ; Arrhythmias, Cardiac ; Constriction, Pathologic* ; Dilatation ; Double-Balloon Enteroscopy ; Edema ; Enteritis* ; Fibrosis ; Hemosiderin ; Hospitalization ; Humans ; Ileum ; Ileus ; Intestines ; Ischemia ; Mucous Membrane ; Nutritional Status ; Ulcer ; Vomiting