Firm, Researchers Urge Caution on AIDS Drug

Newport Pharmaceuticals International Inc. had never enjoyed a terrific batting average in its dealings with the U.S. Food and Drug Administration.

Over a 15-year span the Newport Beach company repeatedly pitched its only drug, Isoprinosine, as a potential cure for a variety of maladies, ranging from mononucleosis to hepatitis. The effort to find a use for the drug even prompted the company to propose it as a learning and memory aid. But each and every time the federal regulatory agency refused to sanction even human testing of the drug, let alone its open sale.

All that, however, changed late last year, when the company hit on another possible use for Isoprinosine: as a treatment for Acquired Immune Deficiency Syndrome, or AIDS.

In November, the FDA gave Newport Pharmaceuticals the go-ahead for human testing of the immune-system-boosting drug at 12 clinics throughout the nation. And just 10 days ago, the company became the nation’s first to win the agency’s approval to dispense its drug through physicians to certified AIDS victims.

Although the agency’s announcement generated bold headlines and revved-up television alerts, company executives as well as medical researchers caution that there’s little scientific evidence to support the conclusion that Isoprinosine can cure, or even retard, AIDS.

“It’s just another good example of the drug-of-the-month syndrome,” noted Dr. Robert Schooley, a Harvard Medical School professor and infectious disease researcher at Massachusetts General Hospital. “There’s really little hard data to distinguish Isoprinosine from the other drugs being studied as AIDS treatments.”

Newport Pharmaceuticals’ executives, although pleased that their drug has finally won recognition, agree that research has yet to prove the effectiveness of the drug against AIDS. “We have no evidence that the drug works on AIDS and we don’t want to build up hopes,” said Sanford Glasky, executive vice president of Newport Pharmaceuticals.

Acknowledged to Be Relatively Harmless

Even the FDA acknowledges that the primary reasons for allowing the drug to be dispensed to diagnosed AIDS victims are that the drug is relatively harmless and already legally available in Mexico, where scores of AIDS victims have been traveling to purchase Isoprinosine.

“With AIDS victims, there’s nothing anyone can do anyway, so why not take a chance?” said Don McLearn, an FDA representative. “We know there isn’t anything harmful about the drug. The question is whether it’s good for anything.”

Isoprinosine, developed by Newport Pharmaceuticals in 1970, boosts the body’s immune system, or its ability to fend off infection and disease. It is licensed for sale in 80 countries either as an immune booster or to treat viruses.

Under the FDA’s latest action, the drug will be sold, at no profit to the company, to physicians for patients diagnosed as having “full-blown” cases of AIDS. Physicians requesting the drug must complete applications and must monitor the progress of their patients, most, if not all, of whom are expected to die from the disease. The company expects to make the first shipments of the tablet-form drug to physicians within a few weeks.

Testing on ‘Pre-AIDS’ Victims

At the same time, Isoprinosine is being tested on “pre-AIDS” victims, or patients known to have been exposed to the deadly HTLV-3 virus believed to cause AIDS. Researchers are trying to determine if doses of the drug will inhibit the disease’s development.

Isoprinosine is one of six drugs currently under evaluation as a possible AIDS fighter and one of two potential AIDS drugs developed by an Orange County company. Viratek Inc., a subsidiary of ICN Pharmaceuticals in Costa Mesa, has developed ribavirin, an anti-viral drug currently being tested on AIDS victims in tests in New York and Paris.

In addition, researchers throughout the world are evaluating the effectiveness of four other drugs on AIDS: HPA-23, under testing in Paris; Suramin, under testing at the National Institute of Health (NIH) in Maryland and other locations; Interleukin and Interferon, also under evaluation at the NIH.

Over the last four years of testing, no drug has shown tremendous promise as an AIDS cure, according to a spokeswoman at the NIH. “So far the patients have all died,” she said. “The drugs haven’t altered the outcome.”