European Stars and Stripes (Newspaper) - December 22, 1985, Darmstadt, Hesse Page 4 the stars and stripes sunday december 22, 1985 panel urges restrictions on use of Jarvik-7 Washington a the Jarvik-7 artificial heart criticized by some advocates of patients rights As causing More suffering than it is Worth should continue to be used in humans but with Case by Casc approval and new reporting restrictions a government advisory panel is recommending. The food and drug administration scientific panel after two hours of Public Testi Mony and about six hours of closed debate voted Friday night to allow the permanent artificial heart program to continue despite a history of strokes and other serious com plications among implant patients. The panel s recommendation is not bind ing on the Fra. But the Agency ordinarily follows such recommendations and will be under special pressure to do so in the highly charged artificial heart Case. The restrictions also include limiting the Jarvik-7 to use As a permanent heart re placement not to its use As a Bridge be tween a failed heart and an anticipated transplant heart. Or. Charles l. Mclntosh a National institutes of health surgeon and chairman of the advisory panel said the committee agreed unanimously to recommend that the experiments continue but under tighter re porting requirements. They w Ould include reports every three months on each patient receiving the Jar Vik-7 As a permanent replacement heart and Fra approval for each operation based on the Success of the previous opera lion. Continued serious medical complications in the next implant patient still could prompt the adv by committee to recommend a halt to to a experiments Mclntosh said. The panel s decision marked a Victory for or. Robert Jarvik Developer of the artificial heart and or. William Duvries the Louisville ky., surgeon who is authorized to perform seven permanent implants. Both worked hard Friday to dissuade the panel from stopping the program. Jarvik testified publicly and met with reporters afterwards. Devries testified extensively in the closed session on medical questions but he did not attend the Public session or a news conference afterwards. They were arguing against critics who said the suffering for the patient in the artificial heart program out highs any be Clit to the patient making it an unethical form of human Annas a patients rights advocate and professor of health Law it Boston University said the devastating results of the first four . Implants justified a halt. The notion that terminally ill people Are somehow fair game for human experimentation has no historical credibility and no medical credibility Annas said arguing that the Fra has a responsibility to protect the terminally ill from improper medical Sidney m. Wolfe director of the Ralph health research group said any of the four patients to Date would have been better off Wilh a natural heart with Jarvik-7 to Iron out the serious problems accompanying its use in humans and thereby exposing More humans seems unscientific As Well As immoral and unethical Wolfe said. It is time to go Back to the drawing Board and More experiments on the Fra four years ago authorized Devries to implant seven permanent artificial hearts. He has completed four opera Lions on Barney Clark in december 1982, William Schmo Cdr in november 1984, Murray Haydon in february 1985 and Jack Burcham in april. Clark and Burcham died Burcham after Only 10 Days. Schroeder and Haydon Are alive but they have suffered serious complications including debilitating strokes and internal bleeding and clotting. Jarvik argued however that All four would have died without the heart. All accepted the risk of an experimental device knowing the Odds were against them he said and knowing their experience could help others. We arc not insensitive to the difficult limes some of the patients and their families have experienced Jarvik said. I care deeply about them. I certainly wish we could have done More. But in View of the severity of the Dis ease and in the context of the history of other new medical devices. The Jarvik-7 heart has performed extraordinarily Reagan hails new7 realism of Congress Thurmont my. A president Reagan said saturday a new bipartisan for eign policy consensus is emerging in con Gress based on sober minded realism and support for a Strong National defense and anti communist movements. In his weekly radio address delivered from the presidential Retreat at nearby Camp David Reagan said the year has seen the emergence in Congress of a new mood a new Point of in the past year. Congress repudiated isolationism and weakness and reasserted America s legitimate world role on behalf of human Freedom he said. He noted that in july the lawmakers approved Aid to anti communist forces whom he described As Freedom fighters in Cambodia Afghanistan and Nicaragua and repealed a ban against such Aid in an Gola. This Effort marked the appearance of a sober minded realism a new willingness to see clearly and to confront the dread effects of communist expansion upon inno cent people like those of Afghanistan and Nicaragua the president said. He called it especially significant that the initiatives were approved by the House which is controlled by democrats As Well As by the Republican led Senate. I am convinced that a new bipartisan foreign policy consensus is emerging one based upon realism and which unites democrats and republicans alike in support of a Strong National defense and help for free Dom fighters around the Globe he said. Donna Reed has pancreatic cancer los Angeles up Academy award winning actress Donna Reed the Star of the Donna Reed show of the 1950s and 1960s who recently filled in As matriarch of the Ewing clan in Dallas has been hospitalized with pancreatic can cer her publicist said saturday. She was admitted to Cedars Sinai medi Cal Center dec. 10, said Hospital spokeswoman Peggy Shaff. Reed 64, was being treated at the medi Cal Center for a recurrence of bleeding ulcers when the pancreatic cancer was discovered said press agent Harry Flynn. This is a
