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DNA technology, and gene cloning in particular, is widely used to produce medicines and to diagnose diseases.

Therapeutic Hormones Consider the first two products in Table 12.6 on the previous pagehuman insulin and human growth hormone. About 2 million people with diabetes in the United States depend on insulin treatment. Before 1982, the main sources of this hormone were slaughtered pigs and cattle. Insulin extracted from these animals is chemically similar, but not identical, to human insulin, and it causes harmful side effects in some people. Genetic engineering has largely solved this problem by developing bacteria that synthesize and secrete the human form of insulin. In 1982, Humulin (Figure 12.7A)human insulin produced by bacteriabecame the first recombinant DNA drug approved by the U.S. Food and Drug Administration. Treatment with human growth hormone (HGH) is a boon to children born with a form of dwarfism caused by inadequate amounts of HGH. Because growth hormones from other animals are not effective in humans, children with HGH deficiency historically have had to rely on scarce supplies from human cadavers or else face dwarfism. In 1985, however, molecular biologists made an artificial gene for HGH

by joining a human DNA fragment to a chemically synthesized piece of DNA; using this gene, they were able to produce HGH in E. coli. HGH from recombinant bacteria is now widely used. Another important pharmaceutical product produced by genetic engineering is tissue plasminogen activator (TPA). If administered soon after a heart attack, this protein helps dissolve blood clots and reduces the risk of subsequent heart attacks. Diagnosis of Disease DNA technology is being used increasingly to diagnose disease. Among the hundreds of genes for human diseases that have been identified are those for sickle-cell disease, hemophilia, cystic fibrosis, and Huntingtons disease. Affected individuals with such diseases often can be identified before the onset of symptoms, even before birth. It is also possible to identify symptomless carriers of potentially harmful recessive alleles (see Module 9.9). Additionally, DNA technology can pinpoint infections. For example, DNA analysis can help track down and identify elusive viruses such as HIV, the virus that causes AIDS. Vaccines DNA technology is also helping medical researchers develop vaccines. A vaccine is a harmless variant (mutant) or derivative of a pathogenusually a bacterium or virusthat is used to stimulate the immune system to mount a lasting defense against that pathogen (see Module 24.4). For many viral diseases, prevention by vaccination is the only medical way to prevent illness. Genetic engineering can be used in several ways to make vaccines. One approach is to use genetically engineered cells or organisms to produce large amounts of a protein molecule that is found on the pathogens outside surface. This method has been used to make the vaccine against the hepatitis B virus. Hepatitis is a disabling and sometimes fatal liver disease, and the hepatitis B virus may also cause liver cancer. Figure 12.7B shows a tank for growing yeast cells that have been engineered to carry the gene for the viruss surface protein. Made by the yeast, this protein will be the main ingredient of the vaccine. Another way to use DNA technology in vaccine development is to make a harmless artificial mutant of the pathogen by altering one or more of its genes. When a harmless mutant is used as a so-called live vaccine, it multiplies in the body and may trigger a strong immune response. Artificial-mutant vaccines may cause fewer side effects than vaccines that have traditionally been made from natural mutants. Yet another method for making vaccines employs a virus related to the one that causes smallpox. Smallpox was once a dreaded human disease, but it was eradicated worldwide in the 1970s by widespread vaccination with a harmless variant of the smallpox virus. Using this harmless virus, genetic engineers could replace some of the genes encoding proteins that induce immunity to smallpox with genes that induce immunity to other diseases. In fact, the virus could be engineered to carry genes needed to vaccinate against several diseases simultaneously. In the future, one inoculation may prevent a dozen diseases. Genetic engineering rapidly transformed the field of medicine and continues to do so today. But genetically modified organisms affect our lives in other ways, as well see next.

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