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Biotech PHARMACEUTICALS and BIOTHERAPY biotech PHARMACEUTICALS and BIOTHERAPY AMERICAN COUNCIL ON SCIENCE AND HEALTH Biotech Pharmaceuticals and Biotherapy by Fredric Murry Steinberg, M.D., M.B.A., and Jack Raso, M.S., R.D. Project Coordinator Simona C. Kwon, M.P.H. Art Director Yelena Ponirovskaya Cover Design Larry Anderson May 1998 AMERICAN COUNCIL ON SCIENCE AND HEALTH 1995 Broadway, 2nd Floor New York, NY 10023-5860 Tel. (212) 362-7044 • Fax (212) 362-4919 URL: http:/www.acsh.org • E-mail: [email protected]. THE AMERICAN COUNCIL ON SCIENCE AND HEALTH (ACSH) APPRECIATES THE CONTRIBUTIONS OF THE REVIEWERS NAMED BELOW. Christine M. Bruhn, Ph.D. Cindy F. Kleiman, M.P.H. University of California, Davis Sisters of Charity Medical Center Staten Island, NY Dale J. Chodos, M.D. Kalamazoo, MI Manfred Kroger, Ph.D. The Pennsylvania State University Ilene R. Danse, M.D. University of California, San Francisco and Floy Lilley, J.D. Davis The University of Texas at Austin Henry G. Grabowski, Ph.D. James D. McKean, D.V.M., J.D. Duke University Iowa State University Saul Green, Ph.D. Gilbert Ross, M.D. ZOL Consultants, Inc. ACSH New York, NY Martha Barnes Stone, Ph.D. Richard M. Hoar, Ph.D. Colorado State University Williamstown, MA Elizabeth M. Whelan, Sc.D., M.P.H. Rudolph J. Jaeger, Ph.D. President, ACSH New York University Ruth Kava, Ph.D., R.D. ACSH ACSH accepts unrestricted grants on the condition that it is solely responsible for the con- duct of its research and the dissemination of its work to the public. The organization does not perform proprietary research, nor does it accept support from individual corporations for specific research projects. All contributions to ACSH—a publicly funded organization under Section 501(c)(3) of the Internal Revenue Code—are tax deductible. Individual copies of this report are available at a cost of $5.00. Reduced prices for 10 or more copies are available upon request. April 1998-02000. Entire contents © American Council on Science and Health, Inc. Table of Contents Reviewers. 2 Executive Summary. 5 Introduction. 6 I. Types of Biotech Pharmaceuticals . 9 Cytokines. 9 Enzymes. 12. Hormones. 13. Clotting Factors. 14. Vaccines. 15. Monoclonal Antibodies. 16. Some Biotech Drugs Undergoing Investigation. .17 . Gene Therapy. 18. II. Safety and Effectiveness. 22. Drug Delivery. .22 . Biotech Pharmaceutical Purity. 23. Biotech Pharmaceutical Stability. 23. III. Regulation of Biotech Pharmaceuticals . .24 . Conclusion . .25 . References . 26. Glossary. 28. List of Tables Table 1: Some Approved Biotech Drugs. 10. Table 2: Miscellaneous Biotech Pharmaceuticals Undergoing Clinical Investigation. .19 . List of Figures Figure 1: Antibodies. 7 Figure 2: A DNA Model. .8 Figure 3: Example of Gene Splicing. .13 . Figure 4: Phagocytosis. 16. Figure 5: A Typical Human Chromosome. 20. Figure 6: Telomerase and Cell Division. .21 . Executive Summary in clinical use are biotech pharmaceuticals. Special A biotech pharmaceutical is simply any Report In a culture where words like “arti- medically useful drug whose manufacture ficial,” “synthetic,” and “man-made” are involves microorganisms or substances that Biotech Pharmaceuticals and Biotherapy and Pharmaceuticals Biotech often used as slurs and the masses increas- living organisms produce (e.g., enzymes). ingly applaud so-called natural healing, a Most biotech pharmaceuticals are recombi- revolution in what might reasonably be nant—that is, produced by genetic engi- termed “unnatural healing” is proceeding neering. Insulin was among the earliest almost full blast—yet so quietly that the recombinant drugs. public has scarcely noticed it. Genetic engineering—also known This revolution—the “biopharm” as bioengineering, gene splicing, and revolution—stems from major advances in recombinant DNA technology—comprises biotechnology, or biotech, a field that altering genetic (DNA) molecules outside encompasses such disparate processes as an organism and making the resultant DNA winemaking, bioconversion (a means of molecules function in living things. Many- recycling organic waste), and cloning. The celled organisms that have been genetically medical repercussions of advances in engineered to produce substances that are biotech have been impressive, but the or may be medically useful to humans implications of those advances for human include cows, goats, sheep, and rats and well-being are no less than staggering. corn, potato, and tobacco plants. “Biotherapy” refers to any treat- In general, recombinant drugs ment that involves the administration of a approved by the U.S. Food and Drug microorganism or other biologic matter. Administration (FDA) are safer than com- Biotherapy’s name may be spanking new, parable natural-substance derivatives: but biotherapy itself is not: Administering Recombinant-DNA processes are precision living things or biologic matter is an techniques that inherently limit contamina- ancient approach to disease. Crude vac- tion. Moreover, many biotech agents are cines were used in antiquity in China, identical to, or differ only slightly from, India, and Persia. Vaccination with scabs proteins the human body produces natural- that contained the smallpox virus had been ly; thus, biotech pharmaceuticals tend to a practice—a dangerous one—in the East have a lower potential for adverse reac- for centuries when, in 1798, English coun- tions. In contrast, most conventionally pro- try doctor Edward Jenner demonstrated that duced pharmaceutical agents designed for inoculation with pus from sores due to treating humans are foreign to, or not nor- infection by a related virus could prevent mally present in, the human body. smallpox far less dangerously. Humankind Genetic engineering is central to has benefited incalculably from the imple- modern biotherapy’s backbone: pharma- mentation of vaccination programs. ceutical biotechnology. Pharmaceutical Another form of biotherapy, insulin biotechnology involves using microorgan- replacement therapy, has been in use for isms, other organisms (e.g., sheep), or decades. Before Canadian physiologists hybrids of tumor cells and white blood Frederick Banting and Charles Best discov- cells: ered and isolated insulin in 1921, nearly all • to create new pharmaceuticals; persons diagnosed with diabetes died with- • to create safer and/or more effective ver- in a few years after the diagnosis. In the sions of conventionally produced phar- mid-1960s several groups reported synthe- maceuticals; and sizing the hormone. • to produce substances identical to con- Virtually all biotherapeutic agents ventionally made pharmaceuticals more 5 Special cost effectively than the latter pharma- Genetic engineering is revolution- ceuticals are produced. izing medicine: enabling mass production Report For example, before the develop- of safe, pure, more effective versions of ment of recombinant human insulin— chemicals the human body produces natu- which became the first manufactured, or rally. Through gene therapy, the potential commercial, recombinant pharmaceutical of biotech pharmaceuticals for curing in 1982—animals (notably pigs and cat- chronic and “incurable” diseases and tle) were the only nonhuman sources of improving the human condition is limit- insulin. Animal insulin, however, differs less. With sensible regulatory require- slightly but significantly from human ments and expeditious product review by insulin and can elicit troublesome the FDA, biotech pharmaceuticals can immune responses. Recombinant human within decades become unprecedented insulin is at least as effective as insulin of relievers of human suffering. animal origin, is safer than animal-source insulin, and can satisfy medical needs Introduction more readily and more affordably. The FDA approved more biotech In the movie Phantoms (1998) a drugs in 1997 than in the previous several scientist, a physician, and a sheriff use a years combined. The laundry list of genetically engineered bacterium to kill a human health conditions for which the Vaselinelike monster. Their use of the FDA has approved recombinant drugs bacterium saves lives in the short term, includes AIDS, anemia, certain cancers but the monster survives. (Kaposi’s sarcoma, leukemia, and †Such In Phantoms biotechnology, or colorectal, kidney, and ovarian films include biotech, was a benign factor, cancers), certain circulatory Island of Lost Souls though not decisively so. Few problems, certain heredi- (1933) and its two remakes (both titled The Island of Dr. major films have depicted tary disorders (cystic Moreau), The Manster (1961), biotech as clearly beneficial. fibrosis, familial hyper- The Cassandra Crossing (1977), Mary Shelley’s horror novel cholesterolemia, Gaucher’s Star Trek: The Wrath of Khan (1982), Species (1995) and Frankenstein: or, The Modern disease, hemophilia A, Species II (1998), and Prometheus, first published in severe combined immunodefi- Alien Resurrection 1818, may have set the tone for (1997). ciency disease, and Turner’s syn- the public’s perception of biotechnol- drome), diabetic foot ulcers, diphtheria, ogy. Since the release of the first screen genital warts, hepatitis B, hepatitis C, version of that classic, in 1910, filmmak- human growth hormone deficiency, and ers have portrayed biotechnology, or what multiple sclerosis. amounts to it, almost invariably as a †† Pharmaceutical Certain Pandora’s box.† In Mimic (1997), for episodes of Star biotechnology’s great- Trek: Deep Space Nine, example, a bioengineer creates a est potential lies in Star Trek: Voyager, The X- cross between a cockroach and a gene therapy.
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