The Los Angeles Times from Los Angeles, California • 5

Tuesday. May 1. 19Ji4Part I 5 Angeles Glme DRUG: FDA Knew of Unauthorized Use iiijiubm iniiii.iiii.i.uiuiiwui -win i nun. in mm iihipwiiil ummm tfpmmmMimmmwmmt there was a broader review in progress. And the agency itself has repeatedly said the drug required FDA approval prior to marketing.

The agency said it also had pending an investigation of a similar new drug, which had sought FDA approval and which. FDA says, exhibited "no similar safety problems." The decision not to act against E-Ferol was made by compliance officials in the agency's Center for Drugs and Biologies, according to FDA spokesman Bruce M. Brown. A spokesman for Carter-Glogau said the company would have no comment on the latest FDA statement. Recall Completed The drug was used as a nutritional supplement, mostly in neonatal intensive care units, because premature infants suffer a deficiency of Vitamin E.

The vitamin is also administered to help prevent blindness among small babies who receive oxygen to keep them alive. Those wjio received E-Ferol developed an unusually abnormal accumulation of fluid in the abdominal cavity, an enlarged liver and spleen and a low blood platelet count. After the first infant deaths were reported, a voluntary recall of E-Ferol was begun, and the FDA said 100 of the drug has now been accounted for. The agency said 54 of the 120,000 ampules were unused and that 46 were administered to patients at 97 hospitals. A definite cause-and-effect relationship between the drug and the deaths and illnesses has not been established.

Investigators say only that there is a "temporal association," in that symptoms developed in those infants after the drug was given and disappeared after the drug was stopped. The Fairfax pharmacist said that he called FDA headquarters in October because he was skeptical of the new drug. The agency, he said, told him it was unapproved and referred him to the manufacturer. He said Carter-Glogau told him the drug did not require FDA approval. "I took it with a grain of salt." he said.

The FDA then reiterated the need for approval, he said, and paid little heed because there was "no imminent health danger." The Fairfax hospital never used the drug. Then in January. Sacred Heart officials in Spokane contacted local FDA officials. Concerned over infant deaths in December and mid-January, the hospital asked the FDA for any clinical or toxicity studies of E-Ferol, Thordarson said. It was told by the FDA that the drug was unapproved.

Sacred Heart discontinued use of the drug, but four infants who received the drug died. Continued from 1 has scheduled an emergency hearing for Friday on the agency's actions. "What protection is the FDA if this sort of thing happens?" asked one congressional staff investigator who asked not to be identified. "If we only find out when somebody dies, we haven't a very effective scher The purpose (of the FDA) is to keep people from dying." When the FDA disclosed the recall on April 12. it linked 12 deaths and five illnesses to the drug: 38 deaths and 43 illnesses have now been tallied at 35 hospitals nationwide.

In a quietly released statementprepared amid a gathering storm of congressional questions, Freedom of Information Act requests and leaks apparently from its own staff the FDA has acknowledged the early warnings it had about E-Ferol Aqueous Solution, an intravenous. Vitamin preparation manufactured by Carter-Glogau of Glendale, and distributed by O'Neal, Jones Feldman Pharmaceuticals of St. Louis. Acknowledges Inquiries The FDA statement said the agency "received several routine inquiries, one as early as November, about whether FDA had approved E-Ferol." (The Fairfax Hospital pharmacist said he contacted the FDA in October after initial promotional materials for the drug were sent to staff physicians and began appearing in trade publications. But FDA spokesmen contend that the agency decided last November no allow the drug to continue on the market nonetheless while it reviewed the safety and efficacy of a broad class of similar drugs.

Since 1962, federal law has required that drugs be safe and effective before they can be sold, but thousands of older drugs, developed before 1962, were permitted to remain on the market pending a determination of their safety and effectiveness. For two decades, FDA has been reviewing those drugs, among them intramuscular and intravenous vitamin and vitamin-and-mineral preparations. The FDA statement said that the "FDA does not normally initiate regulatory action against a specific product until completion of the class review dictates appropriate action for the entire class." The law, Weiss pointed out, nevertheless "requires that all new drugs be approved by FDA," even if ECONOMY: Indicators Down al festivals. Seeking to preserve and revive America own glorious musical theater, it commissions new works and rescues forgotten masterpieces Irom obscurity while developing new artists and audiences Unfettered by government dictates of what culture should be, Kennedy Center operates almost without government funding It thus stands apart from national cultural centers in other parts of the world, where both funding and cultural influence emanate from governmental authority But keeping it as a true people center imposes on the private sector the financial responsibility of meeting much of the Kennedy Center budget The largest segment ol its contributions budget is met by the Corporate Fund for Kennedy Center, an alliance of executives from American businesses, including Mobil For 55,000 your company can be a Corporate Donor; for $50,000 your company can be identified with specific programs. To find out more, please write to Roger B.

Smith, Chairman, The Corporate Fund. The John F. Kennedy Center for the Performing Arts. Washington. DC.

20566. When you help, your employees, customers, suppliers, and the public at large will know that you. too. regard Kennedy Center as the people center. You II be preserving a national treasure.

From its opening night in 1971. the John F. Kennedy Center lor the Performing Arts has been a unique venture. Mandated by Congress as America national cultural center, it nevertheless a people center And that as it should be. At its opera house, concert hall and three theaters, some 16 million lovers ol music, drama, and ballet have attended more than 13.000 performances.

And they re not just the black-tie contingent. They include students, folks with low incomes, the elderly and handicapped, and enlisted military personnel, who are ushered to their seats free or (or half the price, thanks to the nation most extensive reduced-price ticket program. As a people center, it caters to virtually every artistic taste. Performances range from harpsichord recitals to modern musical comedy, opera and operetta, drama and comedy, classical ballet and modern dance. Not only does it present the finest orchestras and artists from this country and abroad but it also nurtures scholarship and innovation through its theater laboratory, national artistic competitions and programs lor young people, and participation in the performing arts library.

Reaching out to the nation, it has brought two million Americans to productions at 450 college campuses and 12 region sumer goods and materials, net business formation and prices of sensitive raw materials. The four indicators that gained in March were vendor performance, contracts and orders for plant and equipment, stock market prices and growth of the nation's money supply. Vendor performance, which measures how fast companies are making deliveries to customers, provided the biggest gain. Continued from Page 1 tion of the economy by as much as six months to a year. Overall, the index in March stood at 165.5 of the 1967 base of 100.

Six of the 10 indicators available for March were down, with the shrinkage in the average work week and new building permits contributing most to the decline. Bad Weather Blamed "Lousy weather took a chunk out of building permits in March and probably hurt a few of the other components as well," said John Albertine, president of the American Business Conference, a coalition of mid-sized, high-growth companies. Other components on the negative side were the average number of new unemployment claims, manufacturers' new orders for con Fordham Given $1 Million NEW YORK OB-Fordham University's School of Law said Monday that it has received a $1 -million gift from the Norman and Rosita Winston Foundation for a chair in memory of Sidney C. Norris, the foundation's late president. Mobil 1 Qnh 1 11,11 1 NEW WAVE TOTE.

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