tag:blogger.com,1999:blog-36762711.post6590938291543970320..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: The More Things Change, The More They Remain The SameRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-36762711.post-13679802887858838292012-07-06T18:50:52.498-04:002012-07-06T18:50:52.498-04:00Documented in plantiffs medical file that patient ...Documented in plantiffs medical file that patient improves, surgery successful. However, documents patient completed at each visit indicated otherwise. In addition, it is illegal not to disclose to patient that doctor has financial ties in a clinical trial. In addition, the patient met exclusion criteria for the surgery, but the doctor proceeded anyway. The mfg reviewed films indicating that a preexisting condition existed, but did not care for the patient after they were informed. They dumped her from the study instead, so her data could not be included in the results reported to the FDA. Disgraceful behavior by all parties involved.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-11994991124734745812008-01-31T13:09:00.000-05:002008-01-31T13:09:00.000-05:00We never said any particular person invented any p...We never said any particular person invented any particular device. We don't know who did and didn't. Besides, that's basically beside the point. The question is did any supposed "conflict of interest" actually affect any research. The article provides zero evidence that this happened.<BR/><BR/>It's product placement for a plaintiff's lawyer masquerading as news.Beck/Herrmannhttps://www.blogger.com/profile/17150638020283243716noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-73041213348125747002008-01-30T19:45:00.000-05:002008-01-30T19:45:00.000-05:00The DDL piece repeatedly suggests that the surgeon...The DDL piece repeatedly suggests that the surgeons about whom the NYT reports were "inventors" of Prodisc. This is simply untrue.<BR/><BR/>Related to Duke's policy on inventors and investors, the article notes:<BR/><BR/>"Duke, Dr. Schulman said, would generally not allow a doctor with a significant financial stake in a drug or device to be involved in a clinical study of it. An exception might be made for a surgeon who invented a new device and had special expertise in its use, Dr. Schulman said. But the Prodisc doctors appear to be simply investors."<BR/><BR/>Duke recognizes the exception. DDL clouds the distinction.Anonymousnoreply@blogger.com