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Arteries, AIDS, and Engineering Analytical Chemistry | Chemical & Engineering News | Modern Drug Discovery | Today's Chemist at Work | E-Mail Us | Electronic Readers Service Table of Contents || 1990s Arteries, AIDS, and Engineering Introduction Whether the changes to the pharmaceutical industry and the world in the 1980s will prove most notable for the rise of and reaction to a new disease, AIDS, or the flowering of entrepreneurial biotechnology and Corporate Sponsors genetic engineering, it is too soon to say. Biotage These changes—along with advances in ChemBridge Corp. Dionex immunology, automation, and computers, Lab Vantage Solutions the development of new paradigms of Pisgah Labs, Inc. Procter & Gamble Chemicals cardiovascular and other diseases, and Shearwater Polymers, Inc. ThermoQuest restructured social mores—all competed Vinchem for attention in the transformational 1980s. AIDS: A new plague It struck the big cities first, and within those cities, at first, it only affected certain segments of the population, primarily homosexual men. The first published reports of the new disease seemed like no more than medical curiosities. On June 5, 1981, the Atlanta-based Centers for Disease Control and Prevention (CDC), a federal agency charged with keeping tabs on disease, published an unusual notice in its Morbidity and Mortality Weekly Report: the occurrence of Pneumocystis carinii pneumonia (PCP) among gay men. In New York, a dermatologist encountered cases of a rare cancer, Kaposi’s sarcoma (KS), a disease so obscure he recognized it only fromdescriptions in antiquated textbooks. By the end of 1981, PCF and KS were recognized as harbingers of a new and deadly disease. The disease was initially called Gay Related Immune Deficiency. Within a year, similar symptoms appeared in other demographic groups, primarily hemophiliacs and users of intravenous drugs. The CDC renamed the disease Acquired Immune Deficiency Syndrome (AIDS). By the end of 1983, the CDC had recorded some 3000 cases of this new plague. The prospects for AIDS patients were not good: almost half had already died. AIDS did not follow normal patterns of disease and infection. It produced no visible symptoms—at least not until the advanced stages of infection. Instead of triggering an immune response, it insidiously destroyed the body’s own mechanisms for fighting off infection. People stricken with the syndrome died of a host of opportunistic infections such as rare viruses, fungal infections, and cancers. When the disease began to appear among heterosexuals, panic and fear increased. Physicians and scientists eventually mitigated some of the hysteria when they were able to explain the methods of transmission. As AIDS was studied, it became clear that the disease was spread through intimate contact such as sex and sharing syringes, as well as transfusions and other exposure to contaminated blood. It could not be spread through casual contact such as shaking hands, coughing, or sneezing. In 1984, Robert Gallo of the National Cancer Institute (NCI) and Luc Montagnier of the Institut Pasteur proved that AIDS was caused by a virus. There is still a controversy over priority of discovery. However, knowledge of the disease’s cause did not mean readiness to combat the plague. Homophobia and racism, combined with nationalism and fears of creating panic in the blood supply market, contributed to deadly delays before action was taken by any government. The relatively low number of sufferers skyrocketed around the world and created an uncontrollable epidemic. Immunology comes of age The 1980s were a decade of worldwide interest in immunology, an interest unmatched since the development of the vaccine era at the beginning of the century. In 1980, the Nobel Prize in Physiology or Medicine went to three scientists for their work in elucidating the genetic basis of the immune system. Baruj Benacerraf at Harvard University (Cambridge, MA), George Snell of the Jackson Laboratory (Bar Harbor, ME), and Jean Dausset of the University of Paris explored the genetic basis of the immune response. Their work demonstrated that histocompatibility antigens (called H- factors or H-antigens) determined the interaction of the myriad cells responsible for an immunological response. Early efforts to study immunology were aimed at understanding the structure and function of the immune system, but some scientists looked to immunology to try to understand diseases that lacked a clear outside agent. In some diseases, some part of the body appears to be attacked not by an infectious agent but by the immune system. Physicians and researchers wondered if the immune system could cause, as well as defend against, disease. By the mid-1980s, it was clear that numerous diseases, including lupus and rheumatoid arthritis, were connected to an immune system malfunction. These were called “autoimmune diseases” because they were caused by a patient’s own immune system. Late in 1983, juvenile-onset diabetes was shown to be an autoimmune disease in which the body’s immune system attacks insulin- producing cells in the pancreas. Allergies were also linked to overreactions of the immune system. By 1984, researchers had discovered an important piece of the puzzle of immune system functioning. Professor Susumu Tonegawa and his colleagues discovered how the immune system recognizes “self” versus “not-self”—a key to immune system function. Tonegawa elucidated the complete structure of the cellular T cell receptor and the genetics governing its production. It was already known that T cells were the keystone of the entire immune system. Not only do they recognize self and not-self and so determine what the immune system will attack, they also regulate the production of B cells, which produce antibodies. Immunologists regarded this as a major breakthrough, in large part because the human immunodeficiency virus (HIV) that causes AIDS was known to attack T cells. The T cell response is also implicated in other autoimmune diseases and many cancers in which T cells fail to recognize not-self cells. The question remained, however, how the body could possibly contain enough genes to account for the bewildering number of immune responses. In 1987, for the third time in the decade, the Nobel Prize in Physiology or Medicine went to scientists working on the immune system. As Tonegawa had demonstrated in 1976, the immune system can produce an almost infinite number of responses, each of which is tailored to suit a specific invader. Tonegawa showed that rather than containing a vast array of genes for every possible pathogen, a few genetic elements reshuffled themselves. Thus a small amount of genetic information could account for many antibodies. The immune system relies on the interaction of numerous kinds of cells circulating throughout the body. Unfortunately, AIDS was known to target those very cells. There are two principal types of cells, B cells and T cells. T cells, sometimes called “helper” T cells, direct the production of B cells, an immune response targeted to a single type of biological or chemical invader. There are also “suppressor” cells to keep the immune response in check. In healthy individuals, helpers outnumber suppressors by about two to one. In immunocompromised individuals, however, the T cells are exceedingly low and, accordingly, the number of suppressors extremely high. This imbalance appears capable of shutting down the body’s immune response, leaving it vulnerable to infections a healthy body wards off with ease. Eventually, scientists understood the precise mechanism of this process. Even before 1983, when the viral cause of the disease was determined, the first diagnostic tests were developed to detect antibodies related to the disease. Initially, because people at risk for AIDS were statistically associated with hepatitis, scientists used the hepatitis core antibody test to identify people with hepatitis, and therefore, at risk for AIDS. By 1985, a diagnostic method was specifically designed to detect antibodies produced against the low titer HIV itself. Diagnosing infected individuals and protecting the valuable world blood supply spurred the diagnosis effort. SOCIETY: Orphans, generics & patents, oh my! Two laws that were passed in the United States in the 1980s had an especially profound influence on the status of the world pharmaceutical industry and on subsequent drug development. The 1983 Orphan Drug Act designated orphan products as those applicable to fewer than 200,000 patients. Benefits of orphan drug designations include seven years of exclusivity of marketing a drug after approval (even if the patent has expired), tax credits of up to 50% of the human clinical research costs, and FDA assistance, if requested, in speeding product development. Some orphan drugs, such as AZT, can prove enormously profitable, and companies have been eager to make use of the designation. The 1984 Drug Price Competition and Patent Term Restoration Act provided defined patent extensions to account for the time a drug is tested and put through the FDA approval process. The act also enables generic drugs that are proven the same as or equivalent to a drug already listed by the FDA to be exempt from repeating By the late 1980s, under the clinical trials before marketing impetus and fear associated permission is granted. This opened with AIDS, both the floodgates to a wave of generics immunology and virology that would transform the received huge increases in pharmaceutical industry. research funding, especially from the U.S. government.
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