- The Washington Times - Monday, April 12, 2004

Twice before when she had come to Washington to be part of an innovative procedure at the National Institutes of Health Clinical Center, Lorie Evilzisor of Urbana, Ohio, had missed seeing the cherry blossoms. This time she got her wish — sort of.

“We saw a few of them,” she said resignedly early last week from her bed in the center with her husband, Brett, by her side.

Two hours later, a cancerous tumor in her right kidney was “cooked” by interventionist radiologist Bradford Wood using radio frequency energy delivered through a needle implanted in her back with the aid of CT scans and ultrasound. When successful, RFA — radio frequency ablation, the procedure’s technical name — kills the tumor tissue without the need for surgery.

Mrs. Evilzisor is one of 77,000 volunteer patients involved in upward of 1,000 clinical trials at NIH, the largest hospital in the world dedicated to clinical research. Figures on the total number of Americans taking part in trials run as high as 6 percent of the population, according to the book “Informed Consent: The Consumer’s Guide to Volunteering for Clinical Trials,” published by Boston-based CenterWatch, a private concern.

The 37-year-old is a volunteer in an ongoing phase 2 trial, also known as a research study, to test capabilities of RFA — a method not regarded as standard care, but using a needle device already approved by the Food and Drug Administration. (Standard care for kidney tumors is surgery, which may lead to the kidney’s removal and perhaps dialysis in the future.)

Phase 1 in clinical trials uses a small number of patients to test the safety of a drug, device or procedure and check for side effects. Typically, healthy volunteers are needed. Phase 2 requires larger numbers, can last many years, and — at least for drugs — will include what are known as randomized trials in which some volunteers receive the current standard treatment or a placebo. Results then are compared and, if warranted, phases 3 and 4 will involve even larger numbers of volunteers to compare the new drug with the commonly used drug. (Only about one-third of drugs make it to phase 3.)

A former medical technician, Mrs. Evilzisor discovered in 1990 that she had inherited a little known genetic disease called Von Hippel-Lindau, or VHL, which causes tumors to grow throughout the body. Having been through nearly a dozen conventional “cut down” surgeries, as she calls them, removing tumors from her spine and brain among other places, she was eager to try RFA.

“I have never taken it as experimental but as research,” she says. “And if I can help somebody else or if there would happen to be a cure [for VHL], I would be part of that.” She isn’t familiar with the terminology “phases” as applied to clinical trials and what they mean, but the risks were spelled out for at her bedside again by Dr. Wood. Mindful that the procedure had worked on her left kidney last year, she signed a final consent form just before getting general anesthesia.

Pharmaceutical company ambitions and the rapid advances in high-tech medicine has made the need for volunteers greater than ever, physicians and researchers say. (Generally only one in five drugs is approved by federal regulators in a process that can take up to 15 years.) Trial participants receive free treatment, and, depending on the type of study, transportation and a nominal amount of money is offered.

Like 39 percent of participating volunteers at NIH, Mrs. Evilzisor was referred by her doctor in Ohio — the ideal, physician-researchers say. But these days nearly all clinical trials must advertise extensively in newspapers and other media outlets. Federal guidelines stipulate that a certain percentage of women and people of ethnic origin must be included, which increases the need for a greater pool of applicants.

“We need a more robust recruitment strategy,” says Dr. John Gallin, director of the NIH Clinical Center, who is worried about the fact that, when asked to name their doctor, nearly 40 percent of people today say it is “Kaiser” or “Blue Cross.” This remoteness between primary care physicians and patients complicates recruitment, he believes. “There is a fear factor that [a volunteer] won’t get the best treatment — or none.”

“Recruitment is the hardest thing about trials and getting people to fit our needs, which vary with the type of trial,” says Claudia Mattil, administrative director at Medstar Research Institute in Hyattsville, adding that finding people who fit what they are testing for is an especially big factor in epidemiological studies, such as a current NIH-sponsored multicenter study testing strategies for treatment in patients who have diabetes and heart disease.

Retired District school teacher and human relations trainer Lawrence Byrd, 82, responded to a newspaper ad and eventually was enrolled in the trial known as BARI 2D (short for bypass angioplasty revascularization intervention 2, and D for diabetes) being conducted under Dr. Michelle Magee, director of the Medstar Diabetes Institute, one of the centers involved.

“I like the culture of the center,” Mr. Byrd says. “The quality of their monitoring is so friendly that my attendance is more person-to-person than patient-doctor. I feel protected. … They’re not guinea-pigging me in terms of giving me new stuff, so it’s all good.” He visits the center at two-to-three-month intervals and, along with several free medicines, receives instructions on diet and nutrition.

Josh, a lawyer who wishes to be known only by his first name, first read about a George Washington University Medical Center experimental trial — it was for a new antidepressant— in a ValuPak coupon envelope sent routinely to Washington-area residents. This particular study is sponsored by Wyeth Pharmaceuticals to test a new medication compared to one of theirs already on the market, says Dr. Daniel Lieberman, assistant professor and clinical director of the department of psychiatry and behavioral sciences at George Washington University. He goes out of his way to praise the courage of volunteers who know they might get a placebo.

“If we eliminated the placebo arm, you can’t tell if a medicine is effective,” he says. “We would stop progress.”

Josh had worried for some time that he had a problem — “waves of anger out of nowhere,” he describes it. Beginning first in a double-blind study, he later was asked to take the experimental drug and now meets face-to-face with a psychiatrist once a month. He likes the privacy — the fact that he is known by a code and his name isn’t released to the sponsor or to any insurance company.

“I don’t want to give the impression I want to help the world,” he says. “This was a safe way to go, an ideal situation for people who have had serious doubts about themselves. … Life is too short to push things off.”

Web sites that explain in detail what is involved for trial volunteers — who can be healthy or in need of medical treatment — include www.cc.nih.gov, www.clinicaltrials.gov or www.nci.nih.gov at the National Institutes of Health (phone, 800/411-1222); www.fda.gov (Food and Drug Administration); and www.centerwatch. com. Types of ongoing trials are listed as well.

A site established expressly for the protection of persons engaged in clinical trials is www.circare.org, which stands for Citizens for Responsible Care and Research. One of its promoters is Ardil Shamoo, professor of biochemistry and molecular biology at the University of Maryland’s School of Medicine, who maintains that oversight is lacking in the enforcement of current federal regulations and that protection of human subjects in research trials is less than that for animal subjects. He bases his opinion in part on what he sees as under-reported numbers of deaths and “adverse events” occurring in trials.

All patients taking part in clinical trials are asked to sign informed consent forms. Before doing so, typical questions would-be volunteers should ask doctors and interviewers include the following:

• What is the study trying to find out?

• Who is sponsoring the study?

• What kinds of tests and exams will I have to take while I am in the study? How much time do these take? What is involved in each test?

• How much time am I expected to give seeing a doctor or clinic?

• Will I be hospitalized? If so, how often and for how long?

• What are the costs involved? Will I be reimbursed in any way?

• What happens at the end of the study? Will there be a follow-up?

• What are my other treatment choices and how do they compare with the treatment being studied?

• What side effects can I expect and how do they compare with side effects of standard treatment? How long will they last?

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