Content provided in partnership with

Three jailed for selling drug that killed 38 babies

FDA Consumer, July-August, 1989 by Catherine Carey

Three Jailed for Selling Drug That Killed 38 Babies

Mr. and Mrs. Harris have mixed emotions. Mrs. Harris just gave birth to a boy, three months prematurely. And, while the couple is overjoyed at having a baby, they are sick with worry about the child's health.

To make matters worse, the oxygen being used to keep the baby's underdeveloped lungs working may also be causing an eye disease called retrolental fibroplasia, which could leave him blind.

But the doctors say they have a new drug--a vitamin E solution--that may prevent the blindness while providing an essential vitamin as well. Maybe it will be the answer to their prayers.

Most Popular Articles in Health: Fuel your workout: exercisers who eat before they work out have more energy ...; Soothe a dry, itchy scalp: 5 easy expert solutions; Cocktails and calories: Beer, wine and liquor calories can really add up. ...; The sour truth about apple cider vinegar - evaluation of therapeutic use; The, six best supplements you've never heard of: these secret weapons can ...; More »

But that was not to be. What started out as a ray of hope for the Harrises ended up tragically with the death of their baby.

The Harrises are a fictitious couple, but the general scenario was real for parents of 38 premature infants who died after being treated with the vitamin E solution called E-Ferol. Now, those responsible are serving prison sentences after being found guilty of breaking the laws designed to protect the public from such unsafe drugs.

E-Ferol Aqueous Solution was the brainchild of James B. Madison, executive vice president of operations at O'Neal, Jones and Feldman (OJF), a drug distribution firm in St. Louis. Madison, with the permission of his boss, Larry K. Hiland, president of OJF, asked Ronald Carter of Carter-Glogau Laboratories, a drug manufacturer in Glendale, Ariz., to develop the formula.

Research of the product by Carter-Glogau amounted to no more than determining how vitamin E could be dissolved in water. Neither company submitted a new drug approval application to FDA, explaining later that they believed their product was a nutritional supplement, not a drug. But because the product was labeled for treating a disease--retrolental fibroplasia--the solution was legally a drug.

OJF began distributing E-Ferol Nov. 8, 1983. One month later, the company received the first report of adverse reactions. A pharmacist and a physician at Kapiolani Children's Medical Center in Honolulu phoned Madison at OJF to report excessive weight gain, swollen abdomens, low blood count, blood clotting abnormalities, and other problems in two infants given the drug. OJF responded by sending them literature on vitamin E.

The second report of adverse reactions came from Sacred Heart Medical Center in Spokane, Wash., on Jan. 24, 1984. A pharmacist from the center called Madison to see if any adverse effects had been seen with E-Ferol. He was told that nothing had been reported. The pharmacist said that the hospital had been using the dosage of E-Ferol recommended in the package insert and several patients had developed unusual symptoms involving kidney function and elevated liver enzymes.

Two days later, on Jan. 26, a specialist in newborns from Sacred Heart called Madison to report that three babies given E-Ferol had died and one was very ill. The physician said that the surviving infant had high levels of vitamin E in its blood. He questioned the safety of polysorbates--ingredients in the E-Ferol preparation--and suggested, in light of the deaths, that the company stop distributing the product, which it did, for a time at least.

On Feb. 1, a pharmacist from the University of Tennessee Hospital in Knoxville called Madison with concerns about the drug. Madison asked if they were having any problems with E-Ferol, and the pharmacist in turn asked if they should be looking for something. Madison told her that nothing in particular had been reported.

Two days later, the pharmacist at Sacred Heart called Madison for more information on E-Ferol, explaining that the drug was the only common factor in the three infant deaths and the sick baby. Madison then suggested, for the first time, that Sacred Heart had used too high a dose of the product, even though it was the dosage recommended in the labeling.

OJF resumed distributing E-Ferol on Feb. 6, 1984. This was just 11 days after the report of the deaths.

On March 26, the University of Tennessee pharmacist called to report that four babies given E-Ferol had died, presumably from liver failure. Madison still insisted that E-Ferol was safe and promised to send the pharmacist information on the polysorbates used in the drug.

Even though at this point OJF knew of eight deaths (the fourth baby at Sacred Heart had also died) possibly caused by E-Ferol, it continued to distribute the drug until April 6, 1984, when an FDA investigator who inspected the firm that day asked the company to stop.

FDA had become involved in the case in April 1984 when the federal Centers for Disease Control notified the agency of reports it had received from two hospitals of clusters of unusual abnormalities in premature infants in neonatal intensive care units.

The agency had known of the product's existence since November 1983, when health professionals questioned whether it was an approved drug. But lacking information regarding the hazards of this unapproved new drug, the agency had not then taken action to remove it from the market.

Three jailed for selling drug that killed 38 babies

FDA Consumer, July-August, 1989 by Catherine Carey

Find Research Guides for:

Find Featured Titles for: Business

Most Popular Articles in Health

Most Popular Publications in Health