Dr. Barry Gingell has come from New York City to San Ysidro, Calif. to defy the Food and Drug Administration, shock his colleagues into action and break the law. Gingell, 30, is going to Tijuana to buy ribavirin and Isoprinosine, drugs not sold in the U.S. but available over the counter in Mexico. Taken together, a practice known as "combination therapy," they constitute a controversial treatment for AIDS-related complex (ARC), the series of symptoms that is often a precursor to AIDS itself. There is no formal evidence that ribavirin and Isoprinosine are useful in treating AIDS; there is some informal evidence that it may be helpful in treating ARC. Says Gingell, who treats nearly 80 ARC patients in his Manhattan practice: "The point is, there's nothing else in the pipeline. These drugs look to be the best thing available for quite some time, and my patients don't have 'quite some time.' "
Since preliminary experience with combination therapy showed promise last year, Mexico has become a mecca for the afflicted. Southern California AIDS projects receive a dozen calls daily about obtaining the drugs and getting them across the border. One bedridden patient phoned an AIDS organization and begged that pills be purchased and mailed to him. For those who stay in the States, the price of hope is high. According to Gingell, one Isoprinosine tablet, which costs 15 cents in Mexico, fetches $15 on the New York black market.
Some AIDS doctors who risk reputations and research funding do not publicly endorse the treatment. Gingell can gamble more because he stands to forfeit less. With no involvement in any established research project or any hospital affiliation, "I don't stand to lose any funding or smear any institution's name," he says. And the public need outweighs the personal consequences, he believes. "With a disease as deadly as this one, you have to bend the rules," insists Gingell, who is gay. "I'd rather lose my license than my friends."
As he taxis to Tijuana, he nervously double-checks the possessions in his pocket. The wad of American Express traveler's checks is for buying the drugs. The doctor's license is to intimidate customs officials if necessary. The Valium is for himself. A novice at smuggling, "I'm all ready to medicate myself if I need to," he jokes.
At the Super Todo farmacia in Tijuana, Gingell is buying 36 boxes of ribavirin and 40 boxes of Isoprinosine, which means several trips to the storeroom across the street for the clerks. "I told them I have very sick patients who need the medicine badly," explains Gingell. "They asked me why I couldn't get the medicine in America. I didn't know the Spanish for 'not allowed.' "
Before his trek, Gingell researched both drugs. A broad-spectrum antiviral agent, ribavirin appears to inhibit the replication of HTLV-III, the virus believed to cause AIDS. Isoprinosine, which is an immune modulator, increases the activity of white blood cells. In some studies, it has enhanced depressed immunity levels.
Unlike Laetrile, which lured desperate patients to Mexico in the past, ribavirin and Isoprinosine are not exotic drugs. Both were developed 16 years ago and are widely used outside the U.S., ribavirin against influenza and childhood pneumonia and Isoprinosine to treat herpes, hepatitis and measles. Isoprinosine is available in 74 countries. Ribavirin is available in about 30 countries. Ironically, although the drugs are unavailable in the U.S., both manufacturers are based in California.
Initially, treating AIDS patients wasn't part of Gingell's practice. Following graduation from New York University Medical School in 1980, he studied computer science at Columbia. After developing a nutritional program, he established a Greenwich Village practice. As a doctor specializing in nutrition, he found his colleagues referring AIDS and ARC patients to him. As a New York gay, he also found his friends among his patients. "By necessity I've become involved on more than a nutritional level," he says.
Judging from the drugstore sales this morning, ribavirin and Isoprinosine have become Tijuana's most treasured exports since divorce decrees. For every store stocked, there are two sold out. In one, the lady painting her fingernails behind the counter says she is out of ribavirin—but she volunteers that she has Isoprinosine before anyone even asks for it. The man standing behind Gingell at the Super Todo counter has the haunted, hollow-eyed look of an AIDS patient. He has just flown in from Hawaii and he carries a red shoulder bag to fill with drugs. He shares customs information with Gingell. As the doctor starts off for another drugstore, the fellow from Hawaii feebly extends the salutation of the season: "See you at the border."
As a joke, the first idea was piñatas. Instead, Gingell decides to hide the contraband at the bottom of shopping bags stuffed with souvenirs. Along the tourist stands, the hawkers look surprised when an American succumbs to the sales pitches so easily.
"I feel like something out of Midnight Express," says Gingell.
"I prefer Julia," says Steven Webb, a friend who has accompanied him on his quest. "It's more elegant."
If caught with undeclared, unlicensed drugs at the border, the violator may face a fine and possible criminal charges. Currently the FDA permits small quantities of an unlicensed drug to be brought into the U.S. for personal use. Since Gingell plans to dispense the drugs, he is in violation of federal law. But not the Hippocratic oath, he insists: "I'm upholding the oath. First, I'm not doing any harm. I'm not withholding known treatment. And I'm doing everything in my power for my patients. If my license were revoked, it would be an outrage."
Ribavirin and Isoprinosine have been approved for investigative testing in the U.S., and FDA approval to license Isoprinosine for use with ARC patients is now pending. The process may take months. "Theoretically any doctor can have Isoprinosine to test on full AIDS patients provided he or she complies with specific rules and regulations," says Alvin Glasky, president of Newport Pharmaceuticals, which makes the drug. But in fact, he says, "we can't just give the drug to anyone who calls us. We want highly qualified physicians who know how to do qualified scientific trials." If testing is not carefully monitored, he warns, the FDA could further delay approval. Currently 10 doctors nationwide are involved in experiments. That translates, says Glasky, into 50 patients. Since 1981 there have been 13,228 AIDS cases reported in the U.S.; 6,758 have died. " 'Soon' is a word I know too well," says Gingell.
Although the drugs are well established internationally for treating other illnesses, their effectiveness combating AIDS and ARC is not. In certain doses, ribavirin has side effects ranging from nausea to anemia. And some doctors believe Isoprinosine might even have the opposite of its desired effect for ARC patients: By stimulating certain parts of the immune system, it may activate the AIDS virus, thus assisting its spread. One study of ARC patients found Isoprinosine has "minimal effects" on immune systems, according to Dr. James Mason, head of the Public Health Service. Says Dr. Michael Roth, a Santa Monica physician with patients who have tried the treatment, "I don't encourage them, but I can't discourage them either. I've not noticed any change in people who take the drugs."
The FDA bristles at suggestions by gay activists that bureaucratic procedures have slowed down approval. Even the Wall Street Journal has decried the situation in an editorial: "What we are dealing with here is regulatory overkill at its worst," said the paper. But FDA spokeswoman Faye Peterson insists, "Rapid progress has been done in all sectors." According to Peterson, the agency is making a "tremendous push" to process applications for potential AIDS drugs.
As they approach the border checkpoint, Gingell steps into one inspection line, Webb the other. If the customs officer discovers the drugs, Gingell intends to identify himself as a doctor. Then he is going to insist on seeing the pertinent statute. If all else fails, he plans to pose as an AIDS patient himself. He recognizes the irony: To get drugs for his patients, the doctor must pass himself off as sick.
"What do you have in there?" the customs officer asks Gingell.
"Some rugs," he answers and then rummages through the bag as if to refresh his memory. "A bottle of tequila, some maracas."
The guard looks Gingell in the eye. "Is that all that's in there?" he asks.
With a wave of the officer's hand, Gingell lumbers through the turnstile and steps into the U.S.
Back at the Economy Motel, Gingell dumps the day's work on the bed: 56 boxes of ribavirin and 60 boxes of Isoprinosine, 1,272 tablets in all. Before returning to New York, he'll make one more run to Tijuana and spend a total of $1,200. "If it doesn't work, it doesn't work," he says. "The patients are no worse off than they were before."
In a subculture where speed is of the essence, the grapevine works as mysteriously as the virus. Even though few friends know of Gingell's journey, there is already a message on his answering machine from a patient eager for the tablets. Suddenly Gingell realizes the other role he must now assume—a reluctant Solomon who will decide which patients get the drugs. As he looks at the boxes before him, his elation erodes. Even after two trips, the haul is only enough for four people for three months. "Oh well," he says with a sigh, "I guess I can't save the world."
- Eleanor Hoover,
- Barbara Lieber.
Like a lot of Americans heading for Mexico this Sunday morning, Barry Gingell is brushing up on his Spanish. Sitting on the edge of a double bed in a budget motel just north of the border, he studies a map of Tijuana. But on this map the usual tourist spots aren't marked. Instead, downtown drugstores are circled. And the Spanish sentence Gingell practices isn't mentioned in most guidebooks. The phrase he wants to perfect is "Give me all."