Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
Los Angeles Times (LT) - SATURDAY June 16, 1990 Edition: Orange County Edition Section: Business Page: 1 Pt. D Col. 5 Word Count: 598
Gregory Crouch; Times Staff Writer
The Costa Mesa-based pharmaceutical company said the Republic of Ireland will allow the sale of ribavirin to treat people infected with the human immunodeficiency virus (HIV), which causes AIDS. People suffering from such HIV symptoms as fevers, night sweats and fatigue would be eligible to receive the antiviral drug.
The World Health Organization estimates that 140 people have contracted full cases of acquired immune deficiency syndrome in Ireland and that nearly 1,000 people are infected with HIV.
The U.S. Food and Drug Administration has refused to approve ribavirin to treat HIV-infected patients and has denied ICN's request to distribute the drug pending approval. The drug, which has been widely marketed by ICN as a cure for several maladies, is viewed with skepticism in some scientific circles as a treatment for AIDS-related illnesses.
ICN announced in March that it had given up trying to win FDA approval for ribavirin to treat HIV patients, even though the company considers the drug effective for that purpose. Ribavirin's only FDA-approved use is to treat severe lower respiratory tract infections in young children.
ICN spokesman Jack Sholl said the company has no plans "at the present time" to reverse its position and seek FDA approval.
Barbara Jones, Ireland's vice-consulate in San Francisco, said her country's minister of health has granted ICN a limited license to sell ribavirin, which means that it will be available to doctors with expertise in AIDS treatment but not to general practitioners.
"We are not promoting the drug," Jones said.
She said Irish doctors generally advocate "early intervention strategies. . . . They have not received an unrestricted license. You can't walk into your pharmacy and get it willy-nilly."
Sholl said he anticipates that several more countries will follow Ireland's lead. The company has asked Canada and Spain, among others, to review ribavirin to treat HIV.
ICN's stock has shot up 76% since June 7. It closed Friday at $4.625 per share, up 50 cents.
"The stock has traded on rumors and speculation for years on whether this drug will ever be approved for an AIDS use," said Ken Bohringer, analyst with the New York brokerage of Prudential-Bache Securities.
Wall Street analysts said ribavirin must still pass many clinical trials before it gains greater acceptance in treating HIV.
"This is a first step, but I wouldn't get wildly enthusiastic," Bohringer said.
Viren Mehta, a researcher with the New York-based pharmaceutical research firm Mehta & Isaly, said, "I don't think many convincing clinical trials have been done to show various health officials in major markets of its real benefits."
Ireland based its approval on two controversial studies conducted in 1986. The first study showed that 10 of 56 people infected with HIV and given placebos advanced to full cases of AIDS within 24 weeks, while just six of 107 HIV carriers treated with ribavirin became seriously ill.
But the methodology was blasted by scientists, including some at the FDA, who called the results meaningless because researchers had not determined that participating AIDS patients were at the same stage of disease.
Dr. Peter Heseltine, associate chairman of medicine at USC, was one of the investigators in the 1986 studies. He said he now thinks that ribavirin could help to delay the onset of AIDS but that new studies are needed to see how it compares to the more widely accepted anti-AIDS drug, azidothymidine (AZT).
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