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Show FDA Admits Error in Not Stopping Sale Of Drug Linked to 38 Infant Deaths - WASHINGTON (AP) The Food and Drug Administration conceded F riday that it erred in failing to stop sales of an unapproved intravenous Vitamin E drug which has been linked to the deaths of 38 premature infants. What we realize with the benefit of hindsight is. that was a wrong decision, said Dr. Harry Meyer, Director of the FDA's Center for Drugs and Biologies. This product should have had more scrutiny than it got, added Dr. Mark Novitch, acting commissioner of the FDA. The two men were among the witnesses called by the House Government Operations subcommittee on intergovernmental relations which was examining the way the FDA handled Aqueous Solution, a a drug made by Carter-Glogawholly-owne- d of Revco subsidiary D.S. Inc. of Twinsburg, Ohio. When FDA was told in November 1983 that the drug was being sold despite the fact that it had not been approved by the agency, one of its compliance officers decided to give the matter a low priority. That officer, James Hamilton, said he made the decision because there was no evidence then of safety problems and because other Vitamin E formulations already were being sold. None of those had FDA approval either, he said. The subcommittee also was told by one doctor that the drug distributor knew that deaths might have been associated with use of as early as January 1984, but that this information was not passed on ol Child Who Survived Crash Wins $660,653 Award - A federal WASHINGTON (AP) jury returned an award of 8660,653 Friday to a Southeast Asian orphan who survived the 1975 crash of an Air Force transport plane in Saigon. The jury in U.S. District Court deliberated two of the li trials 21 days before finding for Marie Jose Patricia Maupoint, who was one of the 145 orphans who survived the crash during Operation Baby Lift, the project sponsored by former President Ford. Charles R. Work, the guardian for the orphans, said of the jury award: We're very pleased. It is a significant verdict for all the European and Canadian Vietnamese children who survived the crash. We hope it will lead to an overall settlement for all of these children. Officials at Lockheed Aircraft Corp., maker of the Air Force C5A transport that crashed in a rice paddy, and a Justice Department spokesman said there would be no comment on the verdict until the record of the trial is reviewed. The crash killed 135 of 330 people aboard, including 98 orphans. Although 52 children now living in the United States have received settlements of their claims, Work has said Lockheed and the U.S. government have refused to settle the remaining 93 cases. These involve children who were adopted in Canada and Europe. Their attorneys have offered to settle the claims for roughly the same amounts paid to the orphans in the an average of United States $300,000 per child. The trial for damages for Maupoint, who was known as Vu Thi Tuong Vi before she was adopte ed by Maupoint of France, was the first of the 93 foreign cases. r, U.S. District Judge Louis F. who presided over the trial, said he expects resolution by trial of the remaining cases is likely to take six years or more unless a settlement is reached. Work has asked President Reagan to help resolve the lawsuits. He also has enlisted the aid of congressional Ma-ga- members to call on the Reagan for support. Work said recently that Lockheed has taken the lead in the courtroom but that the Justice Department can end the litigation by making a settlement offer and thats what we want President Reagan to tell them to do. lh'iiuia lh- - Mt lt Hank ii.ur Rt-l- t hum The 5alt Lake Tribune Novitch said the FDA might have been able to have the drug recalled earlier than it was April 10. 1984 if hospitals which suspected a problem with the drug had informed the agency. He said that although the FDA knew the drug hadn't met its regulatory requirements, it only learned of potential health problems with it on April 2, 1984, from the federal Centers for Disease Control in Atlanta. By Warren E. Leary Associated Press Writer WASHINGTON Depressed levels of a blood protein could be the cause of a rare form of hereditary epilepsy. University of Minnesota researchers said Friday. Dr. Scott Panter said researchers found that many members of families afflicted with the condition have below-normlevels of haptoglobin, a blood protein made in the liver. If further research substantiates the link between A ol A5 5, 1984 May Low Blood Protein Linked to Epilepsy to the FDA. Spokane, Wash., neonatologist who stopped using the drug in his practice in January 1984 after at least three deaths, said he reported those deaths to the drugs distributor, ONeal, Jones and Feldman Pharmaceuticals of Maryland Heights, Mo., the same month. chairman Rep. Ted Weiss, of the subcommittee, said, As far as Im concerned, information such as this is going to be referred to the Justice Department for whatever civil and criminal actions they feel appropriate as far as the distributor and-o- r manufacturer is concerned. Vitamin E drugs have been sold since the 1940s for injection into the muscle and for oral administration. But an intravenous version of the drug had not been made available was sold. until With premature infants. Vitamin E may be given as a nutritional supplement and to treat blindness which sometimes occurs in newborns. . Saturday, Threats No Charges in Alleged Chicago Tribune Service Federal authorities have declined to prosecute minister Louis Farrakhan, leader of the Nation of Islam, in connection with alleged threats against a newspaper reporter made during a March 11 national radio broadcast, U.S. Attorney Dan K. Webb said FriCHICAGO day. Webb said that though the broadcast contained a statement which threatened death, there is insufficient evidence to prove beyond a reasonable doubt that Farrakhan made this statement with the requisite criminal intent necessary to convict under the statue." Webb launched an investigation of the radio broadcast in which the black Muslim leader called black Washington Post reporter Milton Coleman a traitor. During the broadcast, Farrakhan said in reference to Coleman: "One day, soon, we will punish you with death. You say, when is that? In sufficient time. We will come to power right inside this country." haptoglobin and familial idiopathic epilepsy, supplemental treatments of the protein may block the seizures associated with the disease, he told the annual meeting of the American Federation for Clinical Research. An estimated two million Americans suffer from various epileptic disorders believed to be caused by chemical imbalances in the brain or brain injury. Symptoms vary widely and can range from minor lapses in consciousness to violent convulsions. About half of these epilepsy cases can be traced to such known causes as infection, brain trauma, tumors, strokes and exposure to toxic chemicals. The remaining cases have no known cause, but occur spontaneously. Panter told a news briefing that about 5 percent of the epilepsy seen is the inherited, familial variety. Panter, Dr. John Eaton and their colleagues looked at 14 family groups that had members with this kind of epilepsy. In five of these families, 16 of 36 members had low haptoglobin levels, he said, and 10 of these 16 suffered from recurrent seizures. Some unaffected relatives also have low haptoglobin, Panter said. It is possible that some of these ' relatives may also develop epilepsy in the future. Panter and Eaton theorize that a haptoglobin deficiency may lead to seizures because of its relationship with another protein called hemoglobin. court-appoint- ii FIHi lwiljml? ii RflOTKHSR OBJusnr Microwaves TOSHIBA . 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