A defunct Phoenix drug company, its distributor and three people were indicted yesterday on charges of misrepresenting the safety of a drug to treat a disease that can cause blindness in premature infants, even after being warned that several infants had died from ailments associated with the drug.
Carter-Glogau Laboratories, manufacturer of E-Ferol Aqueous Solution, and the drug's distributor, O'Neal, Jones and Feldman of St. Louis, were charged with marketing the drug while knowing that it was potentially dangerous to infants and had not been approved by the Food and Drug Administration.
According to the indictment, Ronald M. Carter Sr., former president of Carter-Glogau, acknowledged to an associate in a 1982 memo that "if we make some attempt to solubilize the vitamin E and use the wrong proportions and kill a few infants, we'd have some serious problems."
Without testing, the indictment said, Carter-Glogau manufactured and shipped 40,000 vials of the drug from November 1983 through April 1984. About 26,000 of the vials were distributed nationwide.
The 25-count indictment, returned by a federal grand jury in St. Louis, also named Carter and Larry K. Hiland and James B. Madison, both former executives of O'Neal, Jones. The defendants were charged with conspiracy to commit mail and wire fraud and violations of the Food, Drug and Cosmetic Act after an investigation by the Justice Department's Civil Division.
E-Ferol, a high-potency vitamin E intravenous solution, was marketed for the treatment of retrolental fibroplasia, which can cause blindness in premature infants.
The defendants developed and marketed E-Ferol despite warnings that the high-potency solution could be toxic and even fatal to premature infants, the indictment said.
As early as January 1984, the indictment said, medical experts warned the defendants that several babies treated with E-Ferol had died from symptoms associated with its use. Yet the defendants continued until April 1984 to tell doctors and hospitals that the product was safe, the indictment said.
The indictment charged that sales representatives of O'Neal, Jones were told to say, if asked, that the FDA had approved E-Ferol for intravenous use.
Madison, former executive vice president of O'Neal, Jones, would not change the drug's label despite being warned by an expert neonatologist in December 1983 that the product, as labeled, would be administered in inappropriately large doses, the indictment said.
Madison was charged with falsely telling pharmacists that no adverse reactions had been reported.
In January 1984, a neonatologist in Spokane, Wash., told Madison that three premature infants had died and a fourth was seriously ill from symptoms associated with the drug. The surviving baby had excessive vitamin E blood levels.
A Tennessee pharmacist told Madison in March 1984 that four babies treated with E-Ferol had died, the indictment said.
That same month, the indictment said, Madison wrote that E-Ferol had made "no claims whatsoever" about the treatment of retrolental fibroplasia and that the product was marketed "solely for use when there is a vitamin E deficiency."
In a January 1984 memo, Madison told an associate that annual sales of E-Ferol could exceed $1.5 million and that the company had "just scratched the surface" of potential business.