Ethics After Hours the Bleeding Edge

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Ethics After Hours The Bleeding Edge Documentary _________________________________________________________________ Summary1 Medical devices can save lives, help us live longer, and improve our quality of life. In The Bleeding Edge, Kirby Dick, Amy Ziering and Amy Herdy explore how lax regulations, corporate cover-ups and the drive for profit in the medical device industry may put patients at risk. The program features cases where medical devices such as Essure (a permanent birth control device), vaginal mesh, the DaVinci Surgical System, and chrome-cobalt hip- replacements have caused irrevocable harm to patients. Director: Kirby Dick Producer: Amy Ziering and Amy Herdy Released: April 21, 2018 Available on Netflix Duration: 1 hours 40 Mins. Discussion questions: • What was your initial reaction to this documentary? • In your opinion, what are the ethical responsibilities of the medical device industry, the medical community, and the government in ensuring patient safety regarding medical devices through approval, usage guidelines, and reporting of adverse events? • Should health care providers be better educated about the approval processes for drugs and medical devices? • According to the documentary, pre-market approval (PMA) for medical devices requires only one clinical trial or study. o Did it surprise you that the approval for medical devices requires fewer steps than the approval of new drugs? o Discuss various reasons for this difference in approval process. Do you believe that it is justified? • What type of regulatory and non-regulatory measures do you think could help alleviate the problems around patient safety outlined in the documentary? 1 This summary is adapted from Wikipedia https://en.wikipedia.org/wiki/The_Bleeding_Edge and Netflix’s website. .

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1 the Bleeding Edge, An Independent Documentary Directed
1 The Bleeding Edge, an independent documentary directed by Kirby Dick and produced by Amy Ziering through their production company, Chain Camera Pictures, unearths systematic corruption within the “$400 billion medical device industry” (The Bleeding Edge 2018). The film takes a deep dive into the healthcare impacts of medical device “innovation” (Dick 2018). Both Dick and Ziering specialize in investigative journalism and documentary having produced the Emmy Award-winning and Academy Award-nominated documentary, The Invisible War (The Bleeding Edge 2018). In all of their documentaries, Dick and Ziering focus on issues of “breaking news,” aiming to inform public opinion, and influence policy (Fuchs 2018). According to Ziering, in an interview by No Film School, when she and Dick decide to make a film they “first get intrigued, then outraged, and then [they] decide to make a movie” (Buder 2018). In the case of The Bleeding Edge, the topic of the film arose when one of Chain Camera Picture’s producers, Amy Herdy, came forward with “this crazy story” about one of her neighbors, who had experienced complications due to an untested medical device (Buder 2018). The disbelief following the interview resulted in an in-depth investigation into this “breaking news,” where research was conducted, and interviews with survivors, professionals, scholars, and doctors were recorded (Fuchs 2018). This information was then synthesized and analyzed, before getting compiled into a commercially consumable film that informs the public of the fractured health system that “has devolved into [a] business” (Fuchs 2018) The Bleeding Edge is an independent film, meaning that,t was not produced in Hollywood and is not backed by any super PACs or the government (Grove 2014).
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