UCLA Criticized for Charging Fees to AIDS Patients in Drug Studies

UCLA Medical School is the only research center in the country charging fees to screen patients for its experimental AIDS drug studies, according to federal health officials, angering physicians and AIDS activists who say the school is trying to make money from a government-subsidized research program.

The school’s AIDS Clinical Trials Unit--one of the 46 sites across the nation chosen to participate in the program to study the effects of new AIDS therapies--is charging patients a $260 “consultation” fee to see if they are eligible for the program. The AIDS trials program, conducted by the National Institute of Allergy and Infectious Diseases, is designed to study promising new AIDS drugs, such as AZT and DDI.

It is up to each AIDS research group to decide whether to charge any fees, and federal officials said they believe that UCLA is the only participating program requesting payment for evaluating study candidates.

“It’s definitely unusual . . . I’ve never encountered it before,” said Dr. Daniel Hoth, director of the AIDS program for NIAID. “Maybe it’s come up with someone else before, but not with the AIDS (program) before.”

However, Hoth added that he did not believe that it would be unreasonable for a program to ask for payment for treatment that a patient would normally pay for. In general, the Food and Drug Administration requires experimental drugs be provided free of charge. . And in this case, Bristol-Meyers Co. is providing DDI free for the clinical trials.

UCLA says it charges the fee because the screenings are part of a larger medical evaluation designed to give AIDS patients numerous treatment options.

“The time that we spend with someone in the clinic is not specifically for participation in the study,” said Dr. David Hardy, co-investigator of the clinical trial’s group at UCLA’s AIDS Research Center. “We discuss much, much more than just the study, such as why they might want to continue taking AZT or why they can’t, and we consider it a medical consultation.

“Once it’s decided that a person is eligible for the study then from then on, all visits are free. But the fee is the same for anyone who comes to UCLA for a medical consultation of any sort.”

But, said Dr. Neil Schram, former chairman of the Los Angeles City/County AIDS Task Force: “They (UCLA) are using this study as a way to make money and in my opinion that is inappropriate. Experimental drug treatment programs are federally funded and they are supposed to be free. What UCLA is doing is wrong.”

AIDS activists also say that the university’s screening fee could exclude poor people who would otherwise be eligible for the study. In addition, insurance companies usually do not provide coverage for treatment involving experimental drugs.

The federally sponsored clinical trials are the nation’s largest source of experimental AIDS care, with a 1989 budget of about $57 million. They are conducted at academic medical centers throughout the country. Since the program began in 1986, more than 7,500 patients have been enrolled, including several hundred at UCLA.

The general policy for the clinical trials is that the patients receive the experimental drugs free in return for their willingness to test the effects of unproven drugs.

Some clinical trial groups across the country, such as one at Tulane University Medical Center in New Orleans, charge patients for AIDS-related medical care that they would require even if they were not involved in the study.

Those eligible for the program include patients who have tested positive for the AIDS virus who have not already taken DDI.

Under the national research program to determine the effectiveness of DDI, two clinical studies will compare patients taking DDI, or dideoxyinosine, to a control group taking AZT, or zidovudine. One control group will be made up of patients who have never taken AZT or who have taken it for a short time. The other control group will use individuals who have taken AZT for more than a year.

A third study will look at AIDS patients who cannot tolerate AZT and will compare a low dose of DDI to a higher dose of the drug.

Federal health officials recently approved widespread distribution of DDI before the clinical studies were completed, after receiving intense pressure from AIDS activists to make promising experimental drugs available for life-threatening conditions.

Like AZT, DDI works by inhibiting replication of the AIDS virus. However, in making it widely available, federal officials said they were concerned about the “potentially serious side effects” of DDI, which recent studies have shown include potentially painful nerve damage to the feet and injury to the pancreas among patients taking large doses of the drug.

AIDS activists are particularly outraged at UCLA’s policy because they say it is unethical to charge a fee to study participants who may be susceptible to increased health risks from the untested drug.

“I think it’s pretty outrageous, especially since you have a situation where people are actually risking their health and they are being charged a fee to enter the program,” said Mark Kostopoulos, a spokesman for AIDS Coalition to Unleash Power. “There is already a problem with minorities and poor people getting experimental drug treatments and this will make it that more difficult to get access to those drugs.”

Hardy said UCLA has already interviewed more than 100 applicants by phone and 20 have been screened in person and charged the $260 fee. USC’s School of Medicine, which also is participating in the study, is not charging patients for the screening. USC officials said more than 100 people have signed up to participate and are on a waiting list. Clinical trials at UCLA and USC will involve more than 300 patients during the next 18 months, according to medical school officials.

Most of the 46 clinical trials will involve about 150 patients each, but each one is run differently. Marti Nash, an administrative nurse at UC San Francisco, which conducts its trials at San Francisco General Hospital, said it is the university’s policy not to charge patients for any care involving new anti-viral drugs, “since we don’t know what the patient care associated with the (drug) treatment would cost.”