Pill Pushing©

The Best of Pill Pushing - AZT – Finally, a drug to fight AIDS - (3/26/2017)

By Dr. Ron Gasbarro
Society at that time: The year was 1987. The AIDS (Acquired Immunodeficiency Syndrome) epidemic had been running rampant in the United States since 1981 and had since become a global killer. There had not yet been a treatment for this disease caused by HIV (human immunodeficiency virus), a retrovirus. By killing or damaging cells of the body's immune system, HIV progressively destroys the body's ability to fight infections and certain cancers. People diagnosed with AIDS may get life-threatening diseases called opportunistic infections, as well as rare forms of cancer. Despite the fear and uncertainty that was plaguing certain populations of people, notably the gay community; nothing was being done on the federal level to investigate it, despite that research was ongoing in the scientific community as early as 1981. 
For President Ronald Reagan, AIDS presented a number of potentially serious political risks. As a presidential candidate, Reagan promised to eliminate the role of the federal government in the limited American welfare state, as well as to raise questions of morality and family in social policy. When AIDS was first reported in 1981, Reagan had recently assumed office and had begun to address the conservative agenda by slashing social programs, cutting taxes and embracing conservative moral principles. As a result, Reagan never mentioned AIDS publicly until 1987. Most observers contend that AIDS research and public education were not funded adequately in the early years of the epidemic, at a time when research and education could have saved lives.
Bad timing in a conservative administration 
In the early 1980s, senior officials from the Department of Health and Human Services pleaded for additional funding behind the scenes while they maintained publicly, for political reasons, that they had enough resources. The Reagan administration treated AIDS as a series of state and local problems rather than as a national problem. This helped to fragment the limited governmental response early in the AIDS epidemic. From a political standpoint, AIDS could not have struck at a worse time. With the election of Reagan in 1980, the "New Right" in American politics ascended. Many of those who assumed power embraced political and personal beliefs antagonistic to gay men and lesbians. Health officials, failing to educate about transmission and risk behavior, undermined any chance of an accurate public understanding of AIDS. The new conservatism also engendered hostility toward those with AIDS. People with AIDS (PWAs) were stigmatized. New Right groups, such as the Moral Majority, successfully prevented funding for AIDS education programs and counseling services for PWAs. At various points in the epidemic, conservatives called for the quarantining and tattooing of PWAs. Jerry Falwell, the leader of the Moral Majority, was quoted as stating: "AIDS is the wrath of God upon homosexuals." 
This larger conservative climate enabled the Reagan administration's indifference toward AIDS. The administration undercut federal efforts to confront AIDS in a meaningful way by refusing to spend the money Congress allocated for AIDS research. In the critical years of 1984 and 1985, according to his White House physician, Reagan thought of AIDS as though "it was measles and it would go away." Although fellow actor Rock Hudson sought help from Ronald and Nancy Reagan and they rebuffed him, his subsequent death from AIDS in 1985 finally prompted Reagan to change his personal views, although members of his administration were still openly hostile to more aggressive government funding of research and public education. Six years after the onset of the epidemic, in 1987, Reagan finally mentioned the word "AIDS" publicly at the Third International AIDS Conference held in Washington, DC. Reagan's only concrete proposal at this time was widespread routine testing. That same year, the Food and Drug Administration finally approved zidovudine (AZT) as the first treatment for AIDS. 

The good, the bad, and the ugly: Originally developed as a chemotherapeutic treatment for cancer, AZT was the first US government-approved treatment for HIV, marketed under the brand name Retrovir. A breakthrough in AIDS therapy, AZT significantly reduces the replication of the virus in patients and leading to clinical and immunologic improvements [Wright, 1986]. It was and is still is used to prevent HIV transmission, such as from mother to child during the period of birth or after a needle stick injury. Used by itself in HIV-infected patients, AZT slows HIV replication in patients, but does not stop it entirely [Jeffries, 1989]. HIV may become AZT-resistant over time, and therefore AZT is only used in conjunction with other anti-HIV drugs in the combination therapy called highly active antiretroviral therapy (HAART). 
When AZT was first released, it was given at a dose of 500 to 1,500 mg/day. Studies show that the higher end of this dosing range contributes to more resistance as well as to the inherent toxicities of this drug and other nucleoside analogues (e.g., blood marrow toxicities, lactic acidosis, anemia, liver disease) [Chiu, 1995]. Today, the recommended dose is 600 mg/day [Zidovudine, 2002]. Cost, at first, was prohibitive. Founded in 1987, AIDS Coalition to Unleash Power (ACT UP) is a New York City-based advocacy group for people with HIV and the grassroots AIDS organization associated with nonviolent civil disobedience. On September 14, 1989, members of ACT UP protested at the New York Stock Exchange over the Burroughs Wellcome's setting a price of $10,000 per year for AZT, which was the only effective treatment for HIV discovered. This price was not affordable to almost all HIV positive persons. Several days later in response to the protest the company lowered the price of AZT to $6,400 per patient per year, which was still a price which almost no one could afford [Engel, 2006]. Today, zidovudine costs around $720/year. However, note that AZT is rarely used alone but is combined with other types of antiretrovirals – that is HAART – which which cost much more but better controls the disease.

Impact of drug on culture:
From the Surgeon General to activism 
Evidently, the approval of AZT was supposed to be enough to settle the gay community and other minorities who have caught HIV. President Reagan successfully prevented his Surgeon General, C. Everett Koop, from discussing AIDS publicly until Reagan's second term. Congress mandates that the Surgeon General's chief responsibility is to promote the health of the American people and to inform the public about the prevention of disease. In the Reagan administration, however, the Surgeon General's central role was to promote the administration's conservative social agenda, especially pro-life and family issues.
At a time when the Surgeon General could have played an invaluable role in public health education, Koop was prevented from even addressing AIDS publicly. Then, in February 1986, Reagan asked Koop to write a report on the AIDS epidemic. Koop had come to the attention of conservatives in the Reagan administration because of his leading role in the anti-abortion movement. Reagan administration officials fully expected Koop to embrace conservative principles in his report on AIDS.
However, when the Surgeon General's Report on Acquired Immune Deficiency Syndrome was released to the public on October 22, 1986, it called for federal action in response to AIDS, and it underscored the importance of a comprehensive AIDS education strategy, beginning in grade school. Dr. Koop advocated the widespread distribution of condoms and concluded that mandatory identification of people with HIV or any form of quarantine would be useless in addressing AIDS. As part of Dr. Koop's broad federal education strategy, the Public Health Service sent AIDS mailers to 107 million American households.

The power of protest
Civil disobedience also helped make headway into getting a response from the government about the AIDS crisis. ACT UP, in the late 1980s and early 1990s, became the flashpoint for protest against governmental and societal indifference to the AIDS epidemic. The group is part of a long tradition of grassroots organizations in American politics, especially those of the African American civil rights movement, which were committed to political and social change through the practice of unconventional politics.
In its effort to attract media attention through direct action, the African American civil rights movement embraced various elements of unconventional politics, including boycotts, marches, demonstrations, and nonviolent civil disobedience. Like other grassroots organizations, ACT UP has been influenced by the civil rights movement to the extent that it, too, has used boycotts, marches, demonstrations, and nonviolent civil disobedience to attract media coverage of its direct action, including the aforementioned incidences of interrupting television network newscasts. On January 22, 1991, during Operation Desert Storm, ACT UP activist John Weir and two other activists entered the studio of the CBS Evening News at the beginning of the broadcast. They shouted "AIDS is news. Fight AIDS, not Arabs!" and Weir stepped in front of the camera before the control room cut to a commercial break. The same night ACT UP demonstrated at the studios of the MacNeil/Lehrer News Hour. The next day activists displayed banners in Grand Central Terminal that said "Money for AIDS, not for war" and "One AIDS death every 8 minutes." One of the banners was handheld and displayed across the train timetable and the other attached to bundles of balloons that lifted it up to the ceiling of the station's enormous main room. These actions were part of a coordinated protest called "Day of Desperation.” 
Big Pharma and the FDA see the handwriting on the wall
ACT UP's original goal was to demand the release of experimental AIDS drugs. However, since its inception, ACT UP has broadened its original purpose to embrace a number of specific and practical goals. ACT UP has insisted that the FDA release antiretroviral drugs in a timely manner by shortening the drug approval process and has insisted that private health insurance as well as Medicaid be forced to pay for experimental drug therapies. Ten years into the AIDS crisis, ACT UP questioned why only one drug, the highly toxic AZT, had been approved for treatment. The organization demanded answers from policy elites. ACT UP also demanded the creation and implementation of a federal needle-exchange program, called for a federally controlled and funded program of condom distribution at the local level, and asked for a serious sex education program in primary and secondary schools to be created and monitored by the United States Department of Education.
ACT UP has also publicized the prices charged and profits garnered by pharmaceutical companies for AIDS drugs. The goal was to put considerable pressure on pharmaceutical companies to cut the prices associated with AIDS drugs so that they would be more affordable to people with HIV/AIDS from all class backgrounds. Class and political economy concerns are not central to ACT UP's ideology, however, but are exposed only to the extent that they inform the larger public of the specific ways in which the group believes that pharmaceutical companies pursue profits at the expense of lives.
From its inception, ACT UP has had a considerable impact on AIDS-related public policy. ACT UP successfully used its nonviolent, direct-action approach to force the FDA to accelerate drug trials for AIDS and to consider ACT UP's "parallel track" proposal. Under this proposal, people with AIDS are given drugs before they are approved by the time-consuming and bureaucracy-ridden FDA approval process. ACT UP's protests also led Burroughs Wellcome to dramatically reduce the price of AZT. Other pharmaceutical companies have been shamed into cutting the prices of drugs that have demonstrated effectiveness in helping people with AIDS. In addition, ACT UP forced the redefinition of AIDS to include women and to ensure that women with AIDS received disability benefits and were included in drug trials. ACT UP members have established needle-exchange programs, which are now widely accepted as having contributed to a decrease in the rate of HIV infection among both injecting drug users and their sexual partners.
By 1996, plagued with internal division over tactics and its relationship to the larger AIDS and gay and lesbian movements and depleted by the deaths of many members, ACT UP still existed but was widely considered moribund. Nonetheless, the organization's use of direct-action politics was an example of the effectiveness of unconventional politics in the face of the unresponsiveness of policy elites. ACT UP's radicalism has also allowed the more mainstream gay and lesbian organizations to seem much more moderate as they interact with the American policy process on AIDS-related issues. In this and in other ways, ACT UP has made an invaluable contribution to saving people's lives in the face of governmental and societal indifference.
Movies have dramatically highlighted the frustration people with AIDS had in obtaining the drugs – many of which were experimental at the time: Examples of movies and TV mini-series that focus on AIDS – that is, the victims and the reactions of those around them – include:
o An Early Frost (1985) [Peabody Award, Emmy winner x 3, Golden Globe winner]
o And the Band Played On (1993) [Emmy winner x 3]
o Angels in America (2003) [Emmy winner x 11, Screen Actors Guild x 12, Golden Globe winners x 5, Pulitzer Prize for the play]
o Dallas Buyer’s Club (2013) [Oscar winner x 3, Screen Actors Guild winner x 2, Golden Globe winner x 2] 
o How to Survive a Plague (2012) [Peabody Award] 
o Longtime Companion (1989) [Sundance Film Festival winner, Golden Globe winner]
o Milk (2008) [Oscar winner x 2, Screen Actors Guild winners]
o Philadelphia (1993) [Oscar winner x 2, Golden Globe winner x 2]
o The Normal Heart (2014) [Screen Actors Guild winner, Golden Globe winner]
Where the drug is today: In the early 1980s, when they HIV/AIDS epidemic began, people with AIDS were not likely to live longer a few years, usually dying from opportunistic infections and cancers. Today, there are 37 antiretroviral drugs (ARVs) and ARV combos approved by the Food and Drug Administration to treat HIV infection. According to the National Institutes of Health (NIH), these therapies do not cure people of HIV or AIDS. Rather, they suppress the virus, even to undetectable levels, but they do not completely eliminate HIV from the body. By suppressing the amount of virus in the body, people infected with HIV can now lead longer and healthier lives. However, they can still transmit the virus and must continuously take ARVs for the rest of their lives, or until a vaccine or a cure is discovered.
AZT is rarely used today. Its legacy will be that it forced society to focus in an otherwise fatal disease attacking groups of people who, otherwise had been marginalized. Meanwhile, the disease is still alive and well. The most recent data from the Centers for Disease Control and Prevention (CDC) show that 1,148,200 Americans aged 13 and older are living with HIV. Of these:
279,100 are female [CDC, 2012] 
76,400 are youths age 13 to 24 [CDC, 2013] 
473,000 have full-blown AIDS, not just infection with HIV [CDC, 2013]
About 18% of those infected with HIV in the United States are unaware of their infection [CDC, 2013]. Young adults ages 25 to 34 accounted for 28% of new HIV infections in the United States in 2011, and young people 13 to 24 years old accounted for 21%. That year, women accounted for an estimated 10,512—or 21%—of the estimated 50,199 new HIV cases in the United States [CDC, 2013]. While progress has been made over the last few decades, current statistics underscore the need for more education, not just of disadvantaged groups, but also of our youth, who did not experience the isolation and discrimination that occurred when the disease was first discovered over a quarter century ago. 
References
Burkett E. The Gravest Show on Earth: America in the Age of AIDS; Boston: Houghton-Mifflin, 1995.
Centers for Disease Control and Prevention. HIV Surveillance Report, 2011; 2013;23. Available at: http://www.cdc.gov/hiv/library/reports/surveillance/2011/surveillance_Report_vol_23.html.   
Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 U.S. dependent areas. 2010 Surveillance Supplemental Report. 2012;17(3, Pt. A). Available at: http://www.cdc.gov/hiv/pdf/statistics_2010_HIV_Surveillance_Report_vol_17_no_3.pdf 
Chiu DT, Duesberg PH. The toxicity of azidothymidine (AZT) on human and animal cells in culture at concentrations used for antiviral therapy. Genetica. 1995;95:103-9.
Engel, J. The Epidemic: A Global History of AIDS. New York: Smithsonian Books/Collins; 2006.
Foreman CH Jr. Plagues, Products, and Politics: Emergent Public Health Hazards and National Policymaking; Washington, D.C.: Brookings Institution, 1994.
Jeffries DJ. Zidovudine resistant HIV. BMJ. 1989;298:1132-3.
Koop, CE. The Memoirs of America's Family Doctor; New York: Random House, 1991.
Moss JJ. "The Czar Trip," The Advocate 696 (December 12, 1995), pp. 22-28.
National Institute of Allergy and Infectious Diseases. HIV/AIDS. Available at: http://www.niaid.nih.gov/topics/HIVAIDS/Understanding/Pages/Default.aspx    
Perrow C, Guillen MF. The AIDS Disaster: The Failure of Organizations in New York and the Nation; New Haven, Connecticut: Yale University Press, 1990.
Shilts R. And the Band Played On: Politics, People, and the AIDS Epidemic; New York: St. Martin's Press, 1987.
Wright K. AIDS therapy: First tentative signs of therapeutic promise. Nature. 1986;323:28


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