THE PURSUIT OF SCIENCE; CUTTING-EDGE TREATMENTS CUT BOTH WAYS.Byline: Phil Davis
WANTED: Human test subjects willing to be poked, prodded, scanned, probed, measured and, eventually, autopsied for lifelong study on aging. Squeamish squea·mish adj. 1. a. Easily nauseated or sickened. b. Nauseated. 2. Easily shocked or disgusted. 3. Excessively fastidious or scrupulous. people need not apply. ``You're there for three days,'' explains Carolyn Nelka, a 10-year veteran of the Baltimore Longitudinal Study longitudinal study a chronological study in epidemiology which attempts to establish a relationship between an antecedent cause and a subsequent effect. See also cohort study. on Aging, ``and you go through an incredible battery of physical, emotional, psychological and spiritual tests. Glucose tolerance, 24-hour urine, a complete physical. I mean complete physical, where they measure your digits. ... It's a lot.'' From the front lines in the war on cancer to new allergy drugs, the research world relies heavily on legions of volunteers who are willing to subject themselves to the science of medicine. ``It's the only way we're going to know what works and how it works,'' said Dr. Lee Rosen, director of cancer therapy research at UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX . The upside: Volunteers often are first to get cutting-edge treatments; they get more access to doctors and specialists; and many studies pay for expensive medical tests or even shell out a couple of hundred dollars for a few hours of work. The downside: Human guinea pigs guinea pig (gĭn`ē), domesticated form of the cavy, Cavia porcellus, a South American rodent. It is unrelated to the pig; the name may refer to its shrill squeal. may first experience side-effects - vomiting vomiting, ejection of food and other matter from the stomach through the mouth, often preceded by nausea. The process is initiated by stimulation of the vomiting center of the brain by nerve impulses from the gastrointestinal tract or other part of the body. , rashes or in some cases death. And, because this often is the first time the treatment has been used on humans, the long-term implications are unknown. No one doubts research is the only way to move medicine forward, but past ethical lapses and the multibillion-dollar stakes of the present-day pharmaceutical industry give clinical trials a checkered check·ered adj. 1. Divided into squares. 2. Marked by light and dark patches; diversified in color. 3. Marked by great changes or shifts in fortune: a checkered career. reputation. In one of the more famous ethical lapses, government researchers in Tuskegee, Ala., charted the effects of untreated syphillis by withholding treatment from 399 African-American men who weren't even told they had contracted the disease. The 40-year experiment ended in 1972 when investigative reporters exposed the unethical unethical said of conduct not conforming with professional ethics. research - leading to strong informed consent laws that require a researcher to explain all treatment options and clearly outline the risks of the research. The government only recently apologized to the surviving men. Dr. Oscar Streeter, a USC An abbreviation for U.S. Code. radiation oncologist radiation oncologist Radiation therapist A radiologist specialized in using radioactive substances and x-rays to treat tumors and CA; an oncologist who uses various formats of radiation to manage CA Salary ± $200K. See Oncologist. who spends time recruiting wary minorities who are poorly represented in clinical studies, said those past errors led to strict federal regulations and ethical review panels that force researchers to prove the merits of their work. ``Nowadays, the paternalism paternalism (p  ·terˑ·n , the I-know-better-than-you has been
eliminated in clinical trials,'' Streeter said. ``Very often,
we say we don't know Don't know (DK, DKed)"Don't know the trade." A Street expression used whenever one party lacks knowledge of a trade or receives conflicting instructions from the other party. what is better.'' But, despite those changes, controversy lingers. Rezulin, a new drug to treat adult-onset diabetes, passed through all three clinical trial phases on a special government ``fast-track'' drug approval program, only to be found to cause potentially fatal liver damage. The number of deaths attributed to the drug - between 33 and 155 - is being hotly debated. But people thinking of volunteering for research should know at least 2 percent of Rezulin test subjects suffered liver damage during the trial, the government reports. And in a 1993 hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic drug trial, five volunteers taking the experimental drug Fialuridine died before scientists realized they had overlooked its deadly potential. So why do people volunteer? ``I just saw it as a wonderful opportunity to learn more about my own body, how my body ages and what I can do to assist my body in reaching its maximum potential and stay there,'' said Nelka, a 57-year-old Baltimore acupuncturist who volunteered for the aging study a decade ago. For others, like Thousand Oaks Thousand Oaks, residential city (1990 pop. 104,352), Ventura co., S Calif., in a farm area; inc. 1964. Avocados, citrus, vegetables, strawberries, and nursery products are grown. software programmer See systems programmer. John Gertwagen, the decision was clear cut - he joined a cancer clinical trial because he was running out of time and options. Gertwagen, 51, had undergone several surgeries and a host of treatments - from radiation to interferon - to eradicate the skin cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping. See also: Cancer hiding in his body. But nothing worked, and he was looking at only a 20 percent chance he would live to see his son graduate high school. He volunteered for a USC clinical trial to test a skin cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. that showed real promise but was untested in humans. ``I figured if I had to go, I could just crawl off in a shell and die or I could make the best of the situation,'' Gertwagen said. ``If it helped, great. And if it didn't, at least I would be helping someone else.'' It helped. His cancer is in remission and he's back at work. ``Three years ago - almost four - I had two years to live,'' he said. Pat McCallick, a retired San Fernando Valley San Fernando Valley Valley, southern California, U.S. Northwest of central Los Angeles, the valley is bounded by the San Gabriel, Santa Susana, and Santa Monica mountains and the Simi Hills. schoolteacher, was in the same boat. The odds of her beating ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast were dwindling dwin·dle v. dwin·dled, dwin·dling, dwin·dles v.intr. To become gradually less until little remains. v.tr. To cause to dwindle. See Synonyms at decrease. , so she joined a gene therapy trial at UCLA's Jonsson Cancer Center. ``It was in conjunction with the chemotherapy that I would have already had anyway, so I thought why not?'' McCallick said. ``I didn't think it could possibly hurt me after reading all their material.'' Her cancer, too, is in remission. Lorie Hellman had few qualms about entrusting her body to a surgeon probing the frontiers of medical science. But the risks seemed too high when it came to making a similar choice for her son. The study the 34-year-old Ventura housewife volunteered for would mean surgery to correct complications from consecutive Caesarean sections caesarean section: see cesarean section. - either the new procedure being tested or a traditional method. But researchers experimenting with a new drug to treat attention deficit disorder attention deficit (hyperactivity) disorder (ADD or ADHD) formerly hyperactivity Behavioral syndrome in children, whose major symptoms are inattention and distractibility, restlessness, inability to sit still, and difficulty concentrating on one thing for any couldn't make the same assurance to her 7-year-old son, Hunter. They offered a promising medication - and a big risk. He had a 50 percent chance of ending up in a placebo group (who usually get a sugar pill), which meant his illness could go untreated for the duration of the experiment. ``My husband and I decided it wasn't right that he might get the placebo and end up getting distracted or acting up and falling behind in school. It seemed a little unethical,'' Hellman said. ``I was interested in helping for the greater good, but I didn't feel like putting him through whatever was for the greater good.'' The key, test subjects agree, is to do a lot of research before signing up for any kind of study. It comes down to a very personal choice. ``I had very little to lose,'' Gertwagen said. ``With other forms of cancer, I might not necessarily have been as enthusiastic.'' For example, he noted that other cancers respond to chemotherapy, where his melanoma resisted that treatment. Also, because he was involved in a Phase I study, there was no chance he would get a placebo. ``I'm not quite so sure how I feel about recommending people take a 50-50 crapshoot,'' Gertwagen said. ``But don't just sit there Don't Just Sit There was a television show on Nickelodeon that first aired in 1988 and lasted for three seasons. The show was a talk show mixed with a comedy. Out of Order was the house band on the series, they would later get to sing on the show as well as participate in and do nothing. Do something. The lesson I learned is that you have to take control of your treatment. ... If you're not an informed consumer, it's a mistake.'' Rosen, the UCLA researcher, agreed. There are risks associated with clinical trials - as there always are when dealing with the unknown - but Rosen said research is the only way to advance science. ``It's hope, but it's realistic hope,'' he said. ``People should participate in clinical trials because they themselves will benefit.'' Clinical trial phases Phase I study: A new research treatment is given to a small number of patients to assess its safety. Volunteers are usually paid. The study is intended to determine what happens to the drug in the human body - how it is absorbed, metabolized and excreted. This is where side effects Side effects Effects of a proposed project on other parts of the firm. are often discovered. About 70 percent of experimental drugs pass this initial phase of testing. Phase II study: The drug is relatively safe and now needs to be tested to see that it has the desired effect on a disease. Phase II studies include hundreds of patients and can last up to two years. Most Phase II studies are randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , which means some patients get the drug and others will get standardized treatment or a placebo. The studies are often ``blinded,'' which means neither the patient nor researchers knows who is getting the experimental drug. Only a third of experimental drugs successfully pass this stage. Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA study: This is the last step before the drug can be approved for release on the market. Phase III studies last several years and include thousands of patients. They are normally randomized and blinded. Seventy percent to 90 percent of drugs that make it to Phase III pass the test. Post-Marketing/Late Phase III/Phase IV studies: The drug is now used in standard treatment regimens but may be further evaluated by its manufacturer to test its effectiveness compared to other drugs. In this phase, a drug is also evaluated for its impact on a patient's quality of life and its cost-effectiveness. Source: National Cancer Institute and Centerwatch. What to ask before treatment Clinical trials are serious - often risky - business. Informed consent laws require physicians to clearly outline the risks as well as the benefits of the treatment and all treatment options before enrolling a patient. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the National Cancer Institute and Centerwatch, you shouldn't join a study unless the following questions are answered to your satisfaction: What is the purpose of the study? Who is sponsoring it? Who has reviewed and approved the study? Where will information from the study go? What kind of tests and treatments are involved and how will they be administered? What is likely to happen in my case with - or without - this new research treatment? How will the study affect my daily life? How long will it last? What are all the treatment options and what are the advantages and disadvantages of each? What side effects can I expect? Will I have to be hospitalized? If so, how often and for how long? Where is the trial being conducted? How will patient safety be monitored? Are there any risks involved in the test treatment? Are there possible benefits? Will there be any costs? Will any of the treatment be free? Will I be monetarily compensated for participating in the study? What happens if I am harmed by the trial and what kind of treatment can I expect if that happens? Can I opt to remain on the treatment, even after termination of the trial? What type of long-term follow-up care is part of the study? - Phil Davis CAPTION(S): Drawing, 2 Photos, 2 Boxes Drawing: (Cover--Color) HUMAN GUINEA PIGS Weighing risks vs. benefits of participating in medical trials Photo: (1) Lorie Hellman, with sons Gunnar, 5, left, and Hunter, 7, chose not to let Hunter participate in an attention deficit disorder study. ``My husband and I decided it wasn't right that he might get the placebo and end up getting distracted or acting up and falling behind in school.'' Eric Grigorian/Special to the Daily News (2) UCLA cancer therapy researcher Dr. Lee Rosen: ``People should participate in clinical trials because they themselves will benefit.'' Hans Gutknecht/Daily News Box: (1) What to ask before treatment (See text) (2) Clinical trial phases (See text) |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion