Becker's Hospital Review

34 CMO / CARE DELIVERY FDA tried to ban vape flavors years before illness outbreak, investigation shows By Maia Anderson T he FDA tried to ban flavored fluids for e-cigarettes four years ago, according to an investigation by the Los Angeles Times. The publication began investigating the issue after more than 800 people were sickened by a mysterious vaping- related illness. The investigation found the surgeon general warned in 2012 that tobacco companies were known to use fruity flavors to hook children as a way to ensure decades of product demand. The FDA had also found some flavored e-cigarettes were shown to be poisonous in high doses. In 2014, a national survey by the FDA and National Insti- tutes of Health asked young people who vaped why they did so, and more than 80 percent said they vaped because "it comes in flavors I like," according to the L.A. Times. The FDA drafted a rule regulating e-cigarettes in October 2015, which required flavored e-cigarettes be removed from the market within 90 days of the rule taking effect. However, in May 2016, when the rule was published, the flavor ban was excluded. Cecilia Muñoz, who was at the time a senior official head- ing the White House's Domestic Policy Council, told the L.A. Times that the FDA "struggled" with assessing the economic implications of such a ban, given that the health benefits and harms were still inconclusive. As the number of people with the vaping-related illness continues to increase and states enact policies banning the sale of flavored vaping fluid, the FDA is under pressure to take federal action. An FDA press officer told the L.A. Times the agency plans on finalizing a compliance policy to clear the market of un- authorized, kid-appealing flavored e-cigarette products." n 'I'm not sure that this is ethical, moral or right': Newark Beth Israel kept patient alive to improve transplant program's survival rate By Mackenzie Bean N ewark (N.J.) Beth Israel Medical Cen- ter allegedly kept a patient in a vegeta- tive state alive for a year to improve its transplant program's survival rate, according to an investigative report from ProPublica. For the investigation, ProPublica reporters interviewed patients, family members, and eight current and former employees at New- ark Beth Israel. ey also reviewed medical records, emails, text messages and audio re- cordings of medical staff meetings that were corroborated by several sources. Six takeaways from the report: 1. e report found hospital metrics influ- enced physicians' treatment decisions for at least four transplant patients. At times, physi- cians failed to consult with patients and fami- lies or withheld care options from them. 2. A large portion of the report focuses on the case of 61-year-old Darryl Young, who has been in a vegetative state since undergoing a heart transplant at Newark Beth Israel on Sept. 21, 2018. Recordings obtained by Pro- Publica show the hospital's transplant team was determined to keep Mr. Young alive, de- spite assuming he would never wake up or regain normal function. "[We] need to keep him alive 'til June 30 at a minimum," Mark Zucker, MD, director of Newark Beth Israel's heart and lung trans- plant programs, says in one recording of a transplant team meeting. 3. June 30 marked the publication date of a federally funded report on transplant survival rates. While Newark Beth Israel had main- tained a high one-year survival rate for heart transplant patients from 2008-17, this rate fell in 2018 for unknown reasons. Six of 38 patients who underwent heart transplants at the hospi- tal died in 2018, which equates to an 84.2 per- cent survival rate. Mr. Young's death would've dropped this rate to 81.6 percent, which falls below the national average and could've put the transplant program at risk of federal penalties. 4. e recordings show Dr. Zucker instruct- ed hospital staff to avoid giving Mr. Young's family the option to withdraw care and switch to palliative treatments until aer September 2019, or one year aer his transplant. "I'm not sure that this is ethical, moral or right, [but it's] for the global good of the fu- ture transplant recipients," Dr. Zucker said in different recording of an April meeting. 5. Newark Beth Israel told ProPublica it's con- ducting an internal investigation of the trans- plant program in response to the report. e hospital declined to comment on Mr. Young's case specifically but told the publication its transplant program "has saved countless lives" and consistently met all regulatory guidelines. "Disclosures of select portions of lengthy and highly complex medical discussions, when tak- en out of context, may distort the intent of con- versations," the hospital said of the recordings. "Our patients are our utmost priority and com- munication with our patients and their families is paramount in enabling our team to provide the best and most comprehensive care." 6. Mr. Young is still alive and in a vegetative state. On Sept. 18 — three days before the one-year anniversary of his transplant — clini- cians told Mr. Young's family he is now stable enough to move to a long-term care facility. n

• Cover