Solving The Mysteries of Life
By Jayne Mackta

Reprinted from Teaching for Healthier Environments, The newsletter of the Resource Center at the Environmental and Occupational Health Sciences Institute, Winter 2001

These are exciting times! The news is filled with potential health benefits as scientists successfully map the genomes of life forms from yeast to humans. Daily, there are reports of breakthroughs never imagined just a few years ago. Human trials have begun to test the first promising vaccine against Alzheimer's disease. Cardiac researchers have shown that a year after patients were treated with gene therapy in order to grow heart blood vessels, they had less pain and fewer adverse complications than people who were given control injections.

The public is witnessing a revolution as science breaks through barriers to understanding what makes all living things the same and different. Using space-age technology and molecular biology, biomedical researchers are collaborating across international boundaries in unprecedented interdisciplinary teams with the goal of advancing medical knowledge. Collectively, they are making major contributions to our knowledge of human and non-human animals and the natural world we share. They are all part of the fascinating field called biomedical research.

Biomedical research is the exploration of life's processes. According to Dr. Michael Kastello of Merck Research Laboratories, "Biomedical researchers are like detectives, seeking to understand what causes diseases and how they develop. " Whether employing viruses to probe the workings of human cells or searching for the genes that play pivotal roles in cancer, these investigators follow the scientific method of hypothesis generation and data gathering under controlled conditions. Working in academic, medical and pharmaceutical settings, they seek to advance knowledge about what is happening when we are healthy and sick and how to understand treatment and prevention of disease.

There are three phases of biomedical research: Basic, Applied and Clinical. Each contributes information to the scientist's search for treatments, cures and ways to prevent disease.

If you think of these phases as building blocks, basic research forms the foundation. it furthers understanding of the physical, chemical and functional mechanisms of life processes and disease. "Basic " research is fundamental and may not have immediate practical value. While basic research is not directed at curing any specific problem, the work lays the foundation for the next stage. For example, studies in mice and rats have demonstrated real biochemical connections between the nervous and immune systems. The data from these studies support the hypothesis that depression and anxiety affect health. Investigators trying to answer the questions like "What causes pain? " are engaged in basic research.

Once investigators understand how a disease disrupts the body's processes, they apply what they know to find treatments, vaccines or therapies. Applied research involves the application of existing information to a specific biomedical problem. For example, researchers working with cloned cells and bio-engineered tissue have created "living skin " to study how the body heals from burns. Another team is studying venom of the Malayan pit viper in hopes of developing a treatment for strokes.

Information discovered through basic and applied research often leads to trials in humans or animals to determine if a new drug, vaccine or procedure is safe and effective. Clinical research is begun after prior studies show that the substance being tested is not harmful in several species of animals, and that it is effective against the particular disease being studied. People who qualify to participate in clinical trials must be fully informed and sign a consent form. Some participants receive the medicine being studied, while a control group receives a placebo. None of the participants knows who gets what.

When a new drug is ready to be tested in humans, the process is again divided into phases. Phase I clinical trials are performed in healthy human volunteers to evaluate safety and tolerance. During Phase II, small numbers of patients with the ailment are involved to obtain information on efficacy and safety. Based on these data, larger studies are conducted to determine the proper dose for treatment. In Phase III, several large, well-controlled trials are performed in patients to establish efficacy and safety and to develop product labeling. Other key studies look at drug interactions, outcomes and special population groups.

There is no question that biomedical research is a complex, costly and time-consuming process. Investigators working in academia, industry, government and major medical centers use a number of methods in their search for answers to some of life's mysteries. Chemical, mechanical, mathematical and computer simulations are useful in the early stages of research. "In vitro" tests using cell and tissue cultures taken from live plants, animals or humans are done "in glass" such as petri dishes or test tubes. Animal models give scientists a way to study how a substance will act in a living system before testing it in humans.

When deciding on the appropriate animal model for human diseases, researchers carefully consider which species are most likely to provide the information they need. In some cases, an animal selected can get the disease being studied naturally. For example, dogs, cats, how, cows and goats all get Lyme disease. There are nearly 100 different kinds of cancers found in non-human animals, many of which are similar to those found in people. In other cases, factors such as life span are relevant. A geneticist looking at the transmission of particular traits works with mice and rats, which reproduce frequently and mature quickly. Although they are among the least utilized animal species, cats are important models for neurological studies due to the close similarity of human and feline brains.

Animals make significant contributions in both basic and applied research. Scientists at the University of California at San Francisco, for example, report that altering a single gene in a certain type of nematode worm makes them live twice as long as usual. The implications for people are speculative, but it is possible that follow-up study could give clues to ways that People could be healthier in their senior years.

According to Chella David, an imrnunogeneticist at the Mayo Clinic in Rochester; Minn., "Transgenic mice [mice with an inserted human gene] are a bridge between laboratory analysis and human trials of new treatments." Dr. David's team have successfully produced transgenic mice with human-like immune systems. By studying which mice get what autoimmune disease, and by carefully controlling for environmental factors, the scientists are working to pinpoint what causes genes to malfunction in diseases such as diabetes, rheumatoid arthritis and multiple sclerosis.

While the benefits to human and animal health cannot be disputed, it is imperative that the conduct and consequences of biomedical march be constantly and critically evaluated from an ethical perspective. Dr. Kastello believes that "the rapid explosion of scientific knowledge and advances in technology present new challenges never conceived of just decades ago. It is up to educators to provide youngsters with the tools and critical thinking skills they will need to grapple with ethical dilemmas arising from scientific advances."

Societal quandaries arising from breakthroughs in genetics, for example, present complicated questions: Should we develop technology to allow couples to select their child's gender? Should a pilot with a genetic predisposition to Huntington's be grounded before he shows any symptoms? Should medical technologies be used to prolong life no matter what the circumstances? Should animals be used in research to develop cures for human diseases?

For resources on biomedical research or information about infusing bioethics into your curriculum, contact The New Jersey Association for biomedical Research. The Association is part of a network of State and National organizations that develop materials and offer programs to foster public understanding.

top

© 1999-2005 New Jersey Association for Biomedical Research
1477 Morris Avenue, Union, NJ 07083
Ph: (908) 964-9449
Fax: (908) 964-9144
info@njabr.org