Despair Yields to Hope : New Drug May Buy Time for Sufferers of AIDS-Related Illness

Twice a week, the 11 people--most of them homosexual men in their 30s--pay a visit to the low, white trailers that house the allergy and immunology clinic at Harbor-UCLA Medical Center.

They roll up their sleeves and get a shot.

Half of them receive a drug, half get a placebo. All of them get hope.

The men include lawyers, doctors, auto mechanics and waiters. They come from Long Beach, Los Angeles and the South Bay. One moved from Tennessee just to become part of the group. Many hold down jobs, but some are so weak that on some days they can hardly get out of bed.

They are willing to test a drug that may not work and may have unpleasant side effects. But their health, and perhaps their lives, are at stake.

AIDS-Related Illness

They are people who have ARC, or AIDS-related complex, a less-virulent form of the deadly immune deficiency disease that leaves the body vulnerable to a variety of infections. But people can die from ARC, and in about 30% of the cases, ARC develops into acquired immune deficiency, according to the federal Centers for Disease Control.

Stopping this progression by restoring the immune system is what these 11 people are trying to accomplish as volunteer patients in a study of the drug thymostimulin, which is marketed in a few European countries but is not available in the United States. Researchers say the drug appears to promote the proliferation of T-helper, or T4, cells, which are key components of the body’s immune system.

Dr. Keith Beck, an infectious-disease specialist on the research team, said the study, which is under way at Harbor’s Research and Education Institute and three other locations in the United States, is the first controlled investigation of the drug in this country utilizing controls approved by the U.S. Food and Drug Administration. It employs a double-blind system, in which neither those administering medication nor the patients know who is getting the drug.

Beck said the work could be “very significant research” if the drug proves to have a powerful effect on the disease. He cautioned that even then, thymostimulin will not be a miracle cure because it does not address the other half of the AIDS and ARC puzzle: how to kill or stop the spread of the HTLV-III virus that causes the disease.

Combined Drugs

However, Beck said thymostimulin could be significant in combination with an anti-viral drug, such as the experimental azidothymidine, or AZT, which the federal government recently approved for use by AIDS patients on a controlled basis because of a successful test. AZT does not kill the virus, but it stops its spread by disrupting the chemical chain it needs to replicate itself.

“We don’t know the ultimate action, but the best hope would be a normal person without the virus, and with a restored system,” Beck said. “This hasn’t happened yet.”

But for now, the people in the test group are focused on at least not getting worse.

“I know half are on the placebo and half on the drug, but everybody is benefitting, just because they feel they are doing something,” said a 29-year-old man called Michael, a former dancer who has been in the test group for three months. “It is giving some sort of hope, letting us do something for ourselves, rather than just sitting around waiting.”

Patients ‘Concerned’

But there is some nervousness. “You get concerned when dealing with an experiment,” said Randy Wendelin, a husky 31-year-old Long Beach actor who is the only patient who would allow the use of his full name. “Is it advantageous or dangerous? But it’s the nature of this disease and people are willing to do experiments.”

So far, the testing program, which got under way last December with the first five patients and is scheduled to continue until next spring, has produced varying results and no trends, researchers said. Patients are supposed to stay in the test group for six months but so far only one has completed the program. Some dropped out because they moved or were unable to get to the hospital regularly.

“Some have gotten worse, some have gotten better, and some are the same,” Beck said. “With those who feel great, their fevers went away and they’ve regained the 10 pounds they lost.”

Three people developed AIDS and died during the course of the test.

Like a Family

The program has created a feeling of family among patients and staff.

“They all become people, they are not guinea pigs,” said Janet Voorhees, the research nurse who administers the shots and takes care of the patients’ health needs.

“There have been times when I have gone home and cried. It’s hard to see people who get so sick and become so helpless. How do you explain that you can’t find out why or stop it?”

Voorhees also listens as the men pour out their angers and fears, and gets excited with them when their T-helper count goes up or they begin to feel better.

‘She Really Cares’

“Janet has been one of the best parts of this program,” Michael said. “She really cares and takes time out to ask you if you have some little ailment, just anything. She is very supportive.”

He said this is vital because there are few people those with ARC can turn to. “Your friends don’t even want to hear about it because it’s not a really up thing,” Michael said.

Kent, a 34-year-old Latino, said he became almost paranoid about people. “Your don’t know whom to trust, not even your friends. You begin to doubt everyone.”

The program has made the men more aware of their health--and prone to raise questions about every little blemish and every little bit of fatigue when they visit the clinic. It has softened fears of death and made them appreciate life more.

“There is a spiritual side to this,” Wendelin said. “Only the sick know what well is. . . . I want to live a long time after this experience.”

Illness Accepted

It has allowed them to go through their feelings of rage and helplessness and to achieve acceptance, which, for some, has a rough edge.

Lee, who is 32 and drove to Los Angeles alone from Tennessee to get into the group a month ago, said he had gone through a gamut of feelings at home and fully accepted what was happening to him.

“Then when I got out here for this, it hit me again, that I do have the virus, I am sick, and until they can show me a drug that kills the virus, I think the ultimate thing is I will die,” he said. “Maybe not in two or three years. I could survive with ARC.”

It also has produced some anger about the placebo method, some saying that there should be a mechanism by which people are switched halfway through the test period.

“It’s tragic for those on placebos,” Michael said, “because they are taking as much time, spending as much to travel to be on this. All they are getting is hope. There should be another way to monitor.”

Method Has Value

Voorhees also said that at first, she had doubts about the fairness of the placebo method, which is standard scientific practice. “I was concerned that someone would come in for six months and get a sugar pill.” But she said she came to understand the value of the testing method. “It really documents the effect of the drug.”

But, she said, “There definitely is a placebo effect because 90% have shown some increase in their complete blood count in the first two weeks. It is hope at work, and a feeling that they’re getting help.”

Beck said there is an ethical question involved in placebo testing and that in October, an interim analysis of test results will be made to determine if there is “overwhelming evidence” that the drug is effective. That could enable the research to be stopped and the FDA then would be able to approve the drug.

Some of the men also are angry that the new AIDS drug, AZT, is not being made available immediately to people with ARC, even though some in the original experimental group were ARC patients.

Goes to Selected Patients

Under the plan announced by the Department of Health and Human Services, the drug will go to AIDS patients who have suffered their first bout of pneumocystis carini pneumonia, the most common infection associated with AIDS. It is expected that 6,000 people--about half of the reported AIDS cases in the United States--will get the drug.

Wendelin said it is unreasonable not to help those who are not as ill as people with AIDS, likening the situation to cures for cancer. “The earlier the disease is attacked, the more likely it is to be cured,” he said.

The research team has to deal with the reality of turning down far more people than are accepted because they do not fit the specific ground rules, or protocols, for the study.

According to Voorhees, some have been rejected because they are too heavily involved in drug use or alcoholism. Some have been unwilling, or unable, to come to the hospital on a regular basis for their shots. Some also will not risk being on the placebo.

Must Have Symptoms

In order to qualify, a person must have swollen lymph glands and one of four ARC symptoms: diarrhea, high fever, significant weight loss, and oral candida or thrush, which is a white fungus in the mouth. The person also cannot have AIDS, which is diagnosed by the presence of one of more of the infections associated with the disease, including pneumocystis carini pneumonia or Kaposi’s sarcoma, a form of cancer.

Beck said people with AIDS were not chosen for the study because of the severity of their illness. “We felt it was hard to demonstrate the statistical effectiveness of the drug when the secondary illnesses are so lethal,” he said.

Sometimes the line between ARC and AIDS is so thin that it is crossed. Voorhees said that two people chosen for the study had developed the pneumonia by the time they came in for their first shots and were sent over to the clinic to be diagnosed for AIDS.

“I’ve talked to 200 or so who do not fit the protocol,” Voorhees said.

No Charge to Patients

People are continuing to be enrolled for the study and four new people will start next week. Patients participate free of charge.

The first death in the study occurred less than a week after the test began last December. “He was very ill,” Voorhees said. “The second who died had an incredibly low immune system at the start.”

The most recent death was in August, and Voorhees said this involved the lowest T-helper cell count of anyone in the study. He started at 28, dropped to an extremely low 4, then went up to 58.

The count of the average healthy person is between 447 and 1,284. The count is based on the number of T-helper cells per millimeter of blood.

Rampant Speculation

Because of the double-blind nature of the test, there is rampant speculation among patients about who is and who is not on the drug. Staff and patients alike say most people on the program like to believe they are receiving the drug.

Voorhees said it really is “hard to say” what the true situation is. “We saw more increases than normal, so we said, ‘Wow, the drug does some good,’ ” she said. “Then we see ARC people who are being considered for the study, and who we know are not on the drug, have major increases or decreases.”

Michael said he has gotten to know about five others in the experiment just by meeting them at the hospital.

“We ask each other how we’re doing, if it’s a good day or a bad day,” he said. “We get to know how we’re all doing. We tell each other our thrush is up, or I didn’t sleep, or I had diarrhea. We really communicate and want to know how the other person is doing. That is a bond for us. We can open up and say, I was at work the other night and I was just exhausted.”

Better Medical Care

Voorhees said that because they are in the test group, many patients probably are getting better medical care than they ever had before. “I’m really impressed with the high percentage of the group that are very caring people,” she said. “There’s a lot of depth to them.”

Wendelin said he “would be lost” if he did not have Harbor-UCLA to go to. “They give regular exams at first and are real good about getting you into the clinic if you have other complications,” he said.

Voorhees said that in her talks with the patients, she urges positive attitudes and proper rest and diets. Stress reduction also is important: “Stress damages the immune system. Even normal stress is a problem.

“Someone with a take-charge attitude does better than someone who is discouraged.”

The patients have come to the experiment with varying degrees of illness, and each sees the situation in his own way.

Life Ruined

Lee, who has dark hair and a slight build, said ARC has ruined his life: “I lost my own business, $25,000 I’d saved, and my health insurance was canceled because they said I had a pre-existing condition. I could have sued the insurance company, but who has the money to take on insurance lawyers?”

He said things began getting bad just a year ago when he started having facial blemishes that would not heal and was tired all the time. By the spring, he was so ill that his doctor said he would die if he did not go to the hospital. Finally, he was diagnosed with AIDS--erroneously, as it turned out--and his doctor discharged him.

“He came in and said you have AIDS, I can do nothing for you, and I’m going to let you go,” Lee recalled. “I felt like I had been totally abandoned. They didn’t know how to deal with it back then.”

Lee said he learned about the Harbor thymostimulin test program in August while in Los Angeles visiting a friend and decided to apply for it after he was denied admittance to a drug-testing program in Tennessee.

“There was no one to drive me, so I just . . . drove the 1,800 miles myself,” he said.

Sleeps Many Hours

Now living in a Los Angeles apartment, Lee said he is so tired much of the time that he sleeps 12 to 14 hours a day.

“I’m not angry, I don’t feel, ‘Why me?’ ” he said. “Back in 1981 and ‘82, when the deaths started, I told myself this is a possibility, it could happen to you.”

Lee said the worst thing about ARC and AIDS is that people in their 30s are being forced to deal with things that normally happen to people 65 or 70. “Your friends are dying,” he said. “I’ve lost 10 people, all very close. There’s a guy in Tennessee I’ll probably never see again.”

Wendelin said the he feels fairly well most of the time, but he does get tired and worries about skin problems. “I guess I’m obsessive about what’s next,” he said.

T-Helper Count Dropped

He said he has not worked since he appeared last spring in “Evita” with the Long Beach Civic Light Opera. Since he started the Harbor program in July, he said, he has had a significant drop in his T-helper count. “I’m told it happens, that it’s variable, but it concerns me,” he said.

He said humor and hope are the things people need to deal with ARC and AIDS: “I have a lot of friends who seem to be surviving this. It has been perceived as being so completely lethal that you need to fight and stay hopeful amidst all this.”

Michael, who is tall and has a muscular dancer’s body, said no one knows he is ill unless he tells them. He considers himself much better off than many in the hospital program. “I’ve always been health-oriented, gone to the gym, and never smoked or used drugs,” he said. “I’ve led a healthy, active life and it’s paying off.”

He said he went through the worst time three years ago, when he came down with what doctors then thought was a rare blood disease. “I nearly died with a 105 fever,” he recalled. “But I came out of it. The doctors didn’t know why. In their minds, it was a miracle.”

Mental Distress

But despite feeling well now, Michael said it isn’t always that way with ARC. “Mentally, there’s a lot of distress,” he said. “Three months ago, I was steadily going down. I became very tired, very fatigued and I had a lot of depression.”

Michael said his illness prompted him to change a lot of attitudes.

“I used to be very down on myself and hard on myself for every little thing,” he said. “Suddenly, material things, the nitty gritty things of life, didn’t matter. I know dying is for everybody. Some go sooner, some know when it will be. I have slowed down, I try to take each day as it comes. If I wake up and feel tired, weak or depressed, I tell myself it is just for today. Tomorrow will be another day.”

Thymostimulin is manufactured by Serono Laboratories of Randolph, Mass. A company spokesman said Serono is spending $1 million on the studies at four research centers: Harbor, Northwestern University and Michael Reese Hospital, both in Chicago, and Mother Cabrini Hospital in New York City. The Harbor study is headed by Dr. Gildon Beall, chief of the Division of Allergy and Clinical Immunology at the medical center.

Developed in Europe

Beck said the drug was developed in Europe in the late 1970s and it was shown to be effective in the stimulation of T-helper cells in people who lacked them, or in instances where medication had destroyed them.

After the identification of AIDS in the early 1980s, it was used on some AIDS patients in Europe, as well as in a small pilot test involving about 20 people in Miami early in 1985. Beck said these people were “pretty far gone” at the time of the test and most of them died.

“We’re not thinking this is a wonder drug that will reverse everything,” Michael said. “It is giving us time to wait for something else to come along, giving us hope.