COLUMN ONE : A Doctor's Dubious Potion : The case of Viroxan, concocted by an Orange County physician in his back-yard guest house, illustrates the difficulty of controlling unproven or worthless AIDS remedies.

TIMES STAFF WRITER

By the time a friend finally found him, Mark Snider had lain helpless in his bathtub for three days. Naked and in shock, he was in the fetal position, his body racked by blood poisoning, pneumonia and severe staph infection.

Snider, a Beverly Hills floral designer with AIDS, recently had begun taking an underground AIDS drug called Viroxan. Four days after he was discovered in the tub, he was dead.

But some of Snider's symptoms were not consistent with AIDS and, after a tip from his lover, the Medical Board of California began investigating his death in late 1989. The probe led to Viroxan's inventor, Stephen Herman, a prosperous Orange County doctor who made it in his back-yard guest house.

Herman had been injecting Viroxan into AIDS patients for more than a year without government permission or reliable evidence that it was safe or effective. Last year, the medical board pressured him into surrendering his physician's license--the first such action in California against what authorities described as AIDS quackery. Herman also was convicted in Orange County on charges of false advertising related to Viroxan sales.

Yet today, Viroxan is being taken by Californians with AIDS. Ordered by federal drug regulators not to experiment on humans in the United States, Herman struck a deal with a controversial research group in Kenya to test Viroxan there, and he continues to tout it as a miracle treatment for AIDS, cancer and other diseases. Viroxan can be obtained in Tijuana.

Meanwhile, Herman plans to sell his potion and spinoff products worldwide. He is negotiating marketing agreements in China, Thailand, Mexico, South Korea and various African nations. To help clinch a deal in China, he enlisted a nephew of Richard M. Nixon.

"I think I will be the wealthiest man in the world," Herman said.

As the Viroxan case illustrates, controlling unproven or worthless AIDS remedies is extraordinarily difficult. The underground industry, health fraud experts say, takes in up to $1 billion in the United States. And it has tens of thousands of ready buyers among AIDS patients desperate enough to try almost anything.

Partly in response to pressure from AIDS activists, the federal government recently speeded up its process for getting new drugs on the market. The government also oversees hundreds of clinical trials of experimental AIDS drugs.

Nonetheless, the traffic in illegal drugs continues to flourish, and prosecutions are rare. Authorities blame weak laws, limited government resources and, in some cases, lobbying by AIDS activists who argue that even useless products should be left on the market if AIDS patients believe that they are beneficial.

Like Herman, purveyors of questionable AIDS drugs who are prosecuted in this country often resurface abroad, where the substances continue to be produced and then filter back into the United States, authorities said.

In California, four men died after taking Viroxan, but each had AIDS and there is no direct evidence that the compound caused their deaths. However, state medical board investigators allege that the deaths of two men were hastened by their involvement with Viroxan and the treatment they received from Herman and a North Hollywood doctor who helped him.

Ten ex-patients are suing Herman, claiming they developed heart disease and other maladies from Viroxan--allegations he denies.

The U.S. Food and Drug Administration concluded last year that there is no evidence Viroxan is effective against the AIDS virus. But with the Kenyan institute now manufacturing the drug, it seems on the verge of being available to far more AIDS patients than ever.

Steve Herman is an articulate, self-confident man of 56. An avid handball player, he is fit looking and given to casual, pastel-colored clothes.

To some patients, he is a caring, intelligent man who almost single-handedly invented a substance that allowed them to keep AIDS at bay for years. "Viroxan saved my life," said Scott Beaty, a Palm Springs pianist who was Herman's first patient.

But others said Herman used them as human guinea pigs in a dangerous, failed experiment that, had it succeeded, would have guaranteed him almost limitless wealth and fame.

"We were as captive to Herman's purposes as the guys in the prison camps were to Mengele's purposes," said Herb Dreiwitz, a Los Angeles photographer, referring to the infamous Nazi doctor who experimented on concentration camp inmates.

"To me, there's no way to look at this except that Herman was out for money, for glory, for power," said Kathleen Schmidt, who led the state medical board inquiry of Herman.

A USC School of Medicine graduate, Herman was a radiologist until 1984, when he was found to have lymph cancer and retired. Until moving to Florida recently, he and his family lived in a $700,000 home in posh Villa Park, sometimes called the Beverly Hills of Orange County.

Herman spent his career reading X-rays and helping make diagnoses. He never received specialized training in immunology, virology or other AIDS-related disciplines. Before he began administering Viroxan in 1988, he had never treated AIDS patients.

Herman says Viroxan is a wonder drug that not only stops the progression of AIDS but cures psoriasis, acne, athlete's foot, arthritis, sunburn and warts. He also says he cured his own cancer with the syrupy liquid, which is derived from citrus extracts and infused with ozone.

Herman's motivation for inventing Viroxan was a very personal one: his stepson, Kenny, was found to have AIDS in 1986.

Haunting medical laboratories and libraries, Herman questioned AIDS researchers about possible breakthroughs. Told that none was expected for years, he bought hundreds of chemicals, set up a makeshift lab in his guest house and set out to cure AIDS himself.

On several occasions his back-yard experiments spun out of control. Like the summer evening in 1987 when, as he lounged beside his pool waiting for a chemical reaction to end, he heard a loud explosion, followed by his wife's screams.

"I hear a shriek and Jeanie's yelling: 'The guest house is on fire!' And I look over and see this mass of flames behind the window," he said, adding that he was able to quickly douse the blaze.

"Everybody thought I was crazy," he said.

Aided by his son, James, a chemist, Herman eventually came up with Viroxan's precursor, a compound he called LP-1. In mid-1988, Herman said, he told a medical equipment salesman about it and the salesman told Beaty.

According to Herman, Beaty soon telephoned him and begged to be put on LP-1. Herman initially declined, saying tests on whether it was poisonous to lab animals were not completed.

But when Beaty showed up at his house the next day, still pleading, Herman relented.

At the time, Herman had no conclusive evidence that LP-1 was safe or effective. It had not been approved for human experimentation by the FDA, which regulates new drugs. Nonetheless, he began injecting it into Beaty.

Herman soon claimed dramatic results. Beaty's T-cell level--a major indicator of the health of an AIDS patient's immune system--soared from 300 to 1,200, Herman said. Within a month, Herman said, Beaty had no AIDS symptoms.

Herman was elated. The change in Beaty, he said, "just seemed to me to be almost miraculous."

Herman soon began injecting a handful of other AIDS patients--and getting what he said were similarly dramatic T-cell increases.

But several prominent AIDS researchers said Herman's claims are not credible.

They said such fluctuations in levels of the cells--which help the body combat infection--are common in AIDS patients, even those receiving no medication.

"T-cells bounce all over the place. . . . There's really no credibility with those kinds of anecdotes," said Paul Volberding, director of AIDS programs at San Francisco General Hospital.

As word spread of Herman's purported successes, AIDS patients flocked to him. Eventually, 50 people were given substantial intravenous doses of Viroxan, although he discussed it with about 500, he said.

Herman says he poured $1 million of his own into developing Viroxan and, at first, did not charge patients. As his patient load and expenses grew, he began asking them for $300 per month, he said.

But one former patient said he had to stop using Viroxan when the price hit $700 a month.

Immediately after Herman began injecting patients with Viroxan, a serious problem arose: the shots--in the hips or buttocks--were excruciatingly painful.

"It's like having cold honey put into your soft tissues," said Jim L., a former user who did not want his full name used.

Herman tried mixing the shots with painkillers. But they were still so bad that most users "never took it more than a week," even though they believed it could save their lives, he acknowledged.

Although he launched his search for an AIDS cure on an idealistic impulse--trying to save his stepson--by late 1988 Herman had a new motive: money.

He patented his invention and began contacting drug companies, hoping to strike a deal to get it onto the commercial market.

At first, some firms expressed strong interest.

Genelabs Inc., a small Redwood City, Calif., firm that develops drugs for treating viruses and cancer, offered to give him research funding, stock benefits and a 5% royalty on LP-1 sales, according to a copy of the proposed contract.

But Herman rejected the offer as "low ball," he said.

Abbott Laboratories, a major drug maker, also said it was interested. But the firm backed off after its tests revealed that LP-1 had "no significant activity against bacteria, fungi or virus including HIV," which causes AIDS, according to a company memo.

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Meanwhile, the problem of the shots remained. Not only were they extremely painful, they were causing hard lumps and even dead flesh at injection sites.

One man developed so much dead tissue on one of his buttocks that he had to have almost half of it surgically removed, according to a state report on the incident, which said his flesh looked mummified.

Eventually, Herman came up with what he thought was a simple solution. He told patients to have rubber tubes, or catheters, surgically inserted in their chests, providing permanent openings for intravenous injections and eliminating the need for shots.

Herman turned for help with the catheter implants to a North Hollywood osteopath, Valentine Birds.

A founder of a holistic medical association, Birds was once placed on probation by the state medical board for allowing employees without doctors' licenses to perform sutures, order X-rays and carry out other medical procedures.

In a self-published newsletter for patients, he lauded himself as "a true medical pioneer" and "an inspirer of vision." His practice included many AIDS patients, and he had unorthodox ideas about treating them.

In an interview, he said he often warned patients that AZT--the only AIDS treatment then approved by the FDA--was "poison."

Instead, he injected them with typhoid vaccine, an unproven treatment he learned about from an article in Spin, a magazine that covers the rock music industry.

By late 1989, Birds had arranged for catheter implants in about 10 patients. In several cases, he falsely wrote in presurgical reports that they had lymphoma, not AIDS--hiding the fact that the tubes were really intended for infusion of Viroxan, according to state officials.

Some of those who got the tubes soon developed severe infections and swelling. In interviews, they said they received little or no instruction in how to keep the catheters sterile and unclogged.

"There was no training or any information given to me about this thing I had in my chest. . . . The (catheter) site got really infected," said Chris Thompson, a former Bible student who had an implant in December, 1989.

Another patient, identified in state medical documents only as Stanley H., developed blood poisoning, fever as high as 105 degrees and uncontrollable shaking within two weeks of getting a catheter.

Viroxan finally came to the attention of authorities with the death of Snider, who became Birds' patient in December, 1988. Before his death about a year later, Snider developed a severe staph infection that authorities said was caused by his catheter.

Not long after he died, the medical board launched an investigation that led to Herman's arrest in January, 1990. But conflict quickly shaped up between the board and the Orange County district attorney's office over what charges to file against Herman.

Board investigators admitted that they could not directly link Viroxan to any of the four patients who died. But they argued that at least two deaths--including Snider's--were hastened by poor treatment and neglect by the doctors, and that both should be charged with manslaughter.

County prosecutors said the case was twice reviewed by homicide specialists but there was not enough evidence to sustain a manslaughter charge. Herman was charged instead with misdemeanor false advertising and pleaded guilty. He was sentenced to a $12,000 fine and three years probation. No criminal charges were filed against Birds.

Herman stopped making and dispensing Viroxan after his arrest, he said. But his legal troubles apparently did nothing to dampen Viroxan's commercial fortunes.

In fact, shortly after Herman's arrest, Orange County pharmacist James Brodsky lined up a group of affluent investors who kicked in several hundred thousand dollars to help finance its further development.

With the fresh funds, Herman continued to promote Viroxan.

In June, 1990, he paid for about a dozen patients to attend an international AIDS conference in San Francisco so they could sing Viroxan's praises to French doctors whom he wanted to perform clinical trials.

The infusion of new funds also allowed Herman to re-contact the FDA and make a sustained effort to get his potion approved.

He had approached the agency before his arrest but soon gave up trying to meet federal testing requirements. Backed by his investors, however, he hired an attorney and submitted to the agency a 700-page document, containing his illegal human test data.

But in a scathing January, 1991, letter, FDA officials said the data did not justify human testing or prove Viroxan was safe and effective.

Herman's testing protocol, they said, "is poorly conceived and does not meet the minimal necessary criteria: no rational study design is described . . . (and) no provision is made for adequate safety monitoring or management of toxicity." The FDA ordered him not to use Viroxan on humans again without prior approval.

In April, 1991, the state medical board--following up on its 1990 arrest of Herman--suspended the medical licenses of Herman and Birds, charging they were an imminent danger to public health and safety.

Herman surrendered his license that August rather than face administrative charges of negligence, incompetence and dishonesty. Birds fought similar charges but lost; his license was revoked.

But Herman had not practiced since his 1984 retirement, and losing his license had little practical impact on him.

Moreover, by that time he had struck a deal with the Kenya Medical Research Institute, a government-owned facility in Nairobi, to run new tests on Viroxan.

The institute, also known as KEMRI, is a controversial one in the world of AIDS research. In 1990, its scientists say they have eradicated AIDS symptoms in dozens of carriers using low-dose alpha interferon. KEMRI began selling its own version of the drug, called Kemron.

But researchers in other countries could not duplicate KEMRI's results and many AIDS patients in the United States gradually lost interest in Kemron. This year, the National Institutes of Health said it completed studies which "do not support an earlier report that Kemron is an effective therapy."

In June, KEMRI published preliminary test results on a substance nearly identical to Viroxan that said it is "of clinical importance in considering new avenues" for treatment of AIDS symptoms.

Herman said that although the tests are incomplete, he plans to sell large amounts of Viroxan within a year to developing countries. To help him with a proposed deal to manufacture Viroxan-laden soap in China, he enlisted Donald A. Nixon, an Orange County businessman and nephew of the former President. The soap, which Herman says has germ-killing properties, will be marketed to hospital scrub nurses.

In Los Angeles, 10 ex-Viroxan takers are suing Herman and Birds, saying that the two conspired to use them as human guinea pigs in an "illegal medical experiment."

The suits charge that Herman and Birds exploited patients for profit, failed to warn them of the true dangers of catheters and used them to collect test data that is scientifically meaningless. Herman and Birds denied the charges.

Those suing believe Herman and Birds robbed them of crucial months when they could have been treated effectively with AZT, rather than wasting their time with Viroxan and typhoid vaccine, said their attorney, Raymond Henke.

But Herman insists that he will be vindicated when KEMRI publishes more advanced test results showing that Viroxan works.

Herman said in an interview in late January that he expected those results to be published within one or two months in a "major international medical journal." In another interview in late August, he said the article has not been published yet, but will be soon.

"Every single word that's been said or printed that's negative will amount to nothing more than a breeze blowing in the wind," he said. "It'll be gone the day this is published."

Henke and his clients have a different view.

"The last months and years of these men's lives were wasted for naught," he said. "No one benefited from this experiment. Not the patients, not the purpose of scientific knowledge of AIDS.

"And least of all the cause of the people who now and in the future will suffer from this horrible disease."

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