ICN Challenges ‘Controversial’ Drug Description

We would like to point out that the antiviral drug ribavirin is not in itself “controversial” (as stated in Gregory Crouch’s June 16, 1990, story, “Ireland Approves ICN’s Ribavirin for Treating HIV”).

At present, ribavirin is authorized for a variety of viral infections in over 30 countries throughout the world.

The Food and Drug Administration authorized the use of ribavirin in the United States in late 1985 for the aerosolized treatment of infants and young children hospitalized with severe respiratory tract infection caused by respiratory syncytial virus (RSV), and since that time over 65,000 babies in the United States have been treated with ribavirin for RSV infection. In addition, 16 other countries outside the United States, including seven European countries, have authorized ribavirin for use in the treatment of RSV.

For well over a decade, ribavirin has been used by some five million patients throughout the world, without significant adverse experience. Other indications for which ribavirin is authorized in countries outside the United States include herpes simplex virus, influenza, hepatitis and measles and chickenpox.

The Army has worked extensively with ribavirin in evaluating its efficacy against viruses. The Army’s most advanced work with ribavirin has been in testing it against the hemorrhagic fevers. An Army study conducted in 1988 in China in conjunction with the Hubei Medical College in Wuhan, China, along with a Centers for Disease Control study with ribavirin against Lassa Fever in Sierre Leone, will form the basis of a new drug application the Army plans to submit to the FDA for marketing authorization for hemorrhagic fever with renal syndrome.

Ribavirin, synthesized in 1970, is scientifically well documented. Over 700 scientific papers have been published in its support. Over 5,400 patients have participated in 139 controlled and non-controlled clinical trials with ribavirin.

What the Times should have said in its June 16 article is that ribavirin was the subject of two clinical trials in 1986 that some considered controversial--not that the drug itself is controversial. Surely, for example, to U.S. infants hospitalized with RSV, patients outside the U.S. hospitalized for severe cases of measles and to patients afflicted with hemorrhagic fevers in African nations, ribavirin is hardly controversial.

JACK SHOLL

Corporate vice president, public relations

ICN Pharmaceuticals Inc.