Reagan, Regulation, and the FDA: The US Food and Drug Administration's Response to HIV/AIDS, 1980-90

Article excerpt

While there has been much effort to refocus the FDA toward patients the past eight years, there has been relative silence from one man: Ronald Reagan.

Wall Street Journal, 13 October, 1988

Each of those folks [AIDS activists] thought there was a drug that was the next magic bullet that could save lives, if FDA would just put them on the market. And so you had this synergy between these ultraliberal AIDS activists and these almost rightwing conservatives who wanted regulation reduced.

Associate Commissioner for Policy and Planning, William Hubbard, 27 July, 2005

I. Background

The first US cases of what became known as HIV/AIDS occurred in the late 1970s. Gay men in San Francisco began showing up at local clinics complaining of swollen glands, and they then began to die of unusual diseases (Kaposi's sarcoma) and a form of pneumonia (pneumocytosis carinii) not commonly seen in the young. In June 1981, the federal Centers for Disease Control's Morbidity and Mortality Weekly Report began alerting doctors nationwide to these new developments. By the end of the year, the number of immune collapse cases in homosexual men rose to 180. In mid-1982, good evidence that the disease was sexually transmitted finally surfaced; at the conclusion of summer, 505 cases had been reported, with 202 dead. (1)

By April 1984, Secretary of Health and Human Services Margaret Heckler announced that scientists had identified the source of AIDS as a retrovirus, soon labeled human immunodeficiency virus (HIV). At the time, there were 4,117 reported cases of AIDS in the US By the beginning of 1985, AIDS had killed an estimated 5,600 Americans. By January 1989, when Reagan left office, there was still only one AIDS drug on the market even though the Centers for Disease Control had confirmed 82,764 cases and 46,344 deaths. (2)

II. President Reagan's Lack of Leadership

Amid this growing public health crisis, the FDA was not given a clear policy direction from Washington. The historical record indicates that President Ronald Reagan's leadership on the HIV/AIDS issue was in fact lacking. According to Associate Commissioner for Policy and Planning William Hubbard, it was perceived "within the FDA that the Reagan administration didn't want to talk about AIDS for a long time." (3) And, Hubbard added, "AIDS activists concluded that the agency was sitting on lifesaving AIDS drugs and refusing to let patients have them, sort of a ban by the social conservatives." (4) By other accounts, the president was "uncomprehending," "dithering," and "slow to confront the issue." (5)

President Reagan's response to HIV/AIDS was indeed questionable. First, he mentioned HIV/AIDS only once publicly before the film actor Rock Hudson (a friend of Reagan's from his Hollywood days) died of AIDS in October 1985, at which point the president asked for more information from the White House physician. Reagan did not speak of AIDS again until February 1986 when he instructed his Surgeon General, C. Everett Koop, to report on the problem. Second, Reagan deigned to ignore the counsel of his wife, who pushed him to endorse the use of condoms. Third, the president allowed his staff to delete mention of Ryan White from a widely awaited address in May 1987 to the American Foundation for AIDS Research. White, a hemophiliac teenager who had been ostracized in his hometown of Kokomo, Indiana, after he had contracted AIDS from a blood-clotting agent, was a pointed example of how anyone could contract the disease. Fourth, in June 1987, the Reagan administration established a presidential commission on HIV/AIDS. Its mission was to investigate the disease in its entirety and recommend solutions. After conducting hearings into all aspects of the situation, the presidential commission produced a report in June 1988 which offered a number of measures. According to the House Committee on Government Operations, the president's response to the recommendations was to shelve them until his White House staff had properly studied them. …