U.S. Charges Safety, Effectiveness of Drug Misrepresented
WASHINGTON (AP) _ A federal grand jury in St. Louis, Mo., on Thursday charged a drug manufacturer, a distributor and three individuals with misrepresenting the safety and effectiveness of a drug used in treating premature infants.
The indictment alleged that the drug company received reports that ″several infants″ treated with the drug died from symptoms associated with the product’s use. Amy Brown, a Justice Department spokeswoman, said she could not confirm that infants had died.
Assistant Attorney General Richard K. Willard, head of the Justice Department’s civil division, said the indictment alleged that the manufacturer and distributor of E-Ferol Aqueous Solution knew the drug was potentially dangerous to the health of infants and had not been approved by the Food and Drug Administration for its intended use.
The indictment charged that Carter-Glogau Laboratories, Inc., the drug’s manufacturer, formerly of Phoenix, Ariz., and O’Neal, Jones and Feldman Inc., the drug’s distributor, formerly of St. Louis, ″developed, manufactured and marketed E-Ferol without any scientific testing to determine whether it was safe and effective for use in premature infants.″
Despite the lack of testing, the indictment said, Carter-Glogau and O’Neal, Jones indicated to physicians specializing in the care of premature infants and to other medical professionals that E-Ferol could be used to treat retrolental fibroplasia, a disease that can cause blindness in premature infants.
The indictment alleged that in October 1983, O’Neal, Jones sales representatives were told to say, if asked, that E-Ferol was approved by the Food and Drug Administration for intravenous use.
Between November 1983 and April 1984, Carter-Glogau manufactured and shipped to O’Neal, Jones about 40,000 vials of E-Ferol, about 26,000 of which were distributed to doctors and hospitals nationwide, the indictment charged.
Until April 1984, the drug manufacturer and distributor ″continued to represent to medical professionals that E-Ferol was safe and did not disclose to anyone using or considering using the product the severe adverse reactions and deaths which had been reported to them,″ the indictment said.
Those adverse reactions included excessive weight gain, abdominal enlargement and liver problems.
The indictment further alleged that all the defendants knew by Dec. 19, 1983, that ″there were questions by scientific researchers concerning whether Vitamin E acetate (the type of Vitamin E used in E-Ferol), when administered intravenously, did in fact reduce the severity and incidence of retrolental fibroplasia.″
Carter-Glogau voluntarily recalled the drug in April 1984, Ms. Brown said.
Named in the indictment besides Carter-Glogau, which is now known as Retrac, Inc., and O’Neal, Jones, which is now known as O’Neal, Inc., were Ronald M. Carter Sr., former president of Carter-Glogau; Larry K. Hiland, former president and chief executive officer of O’Neal, Jones; and James B. Madison, former executive vice president of O’Neal, Jones, and the official responsible for product development and regulatory compliance.
They are charged with conspiracy to commit mail and wire fraud through letters mailed to hospitals and through phone conversations with medical professionals. They also are charged with violating the Food, Drug and Cosmetic Act for marketing a new drug without FDA approval.
Efforts to reach the defendants were unsuccessful.