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John-Manuel Andriote Headshot

Who Decides? 'Right-to-Try' Law's Unacknowledged, Deep Roots in AIDS Activism

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It's ironic to hear lefties lambaste Colorado's new "right-to-try" law as something that emerged from the corporation-coddling right wing. They apparently missed some of the most important lessons of the 33-year-old AIDS epidemic.

The right-to-try legislation, just signed into law by Colorado's Democratic Governor John Hickenlooper, gives terminally ill people the legal right to access experimental medical treatments that have passed the phase one safety evaluation required of all potential therapeutic drugs before they can move into phases two and three of the Food and Drug Administration's three-phase drug trials. Missouri and Louisiana also are considering right-to-try laws.

Some are calling it the "Dallas Buyers Club Law" because the Hollywood movie apparently was their introduction to what has actually been a very long battle over who -- the government or the individual, in consultation with doctors -- has the right to determine what level of risk is acceptable where it comes to using a medication that may, or may not, be effective in a last-ditch, life-or-death situation.

The argument at the core of right-to-try -- who gets to decide -- was the catalyst and driving force of the AIDS activist movement. In a famous speech on March 10, 1987 -- a week before the FDA approved AZT, the first-ever treatment for HIV, and 27 years before "Dallas Buyers Club" won its Academy Awards in March -- Larry Kramer pointed out to a group of 250 men and women at New York's Gay and Lesbian Community Center that FDA approval of a new drug at the time could easily take 10 years. "Ten years!" he said. "Two-thirds of us could be dead in less than five years."

Kramer criticized the FDA's speeded-up trials of AZT and plans for the drug's then-imminent approval. One of his biggest targets was the FDA itself and what he called the "exceptionally foolish" double-blind studies ordinarily used to test drugs. The studies are called double-blind because neither the patient nor the doctor knows whether the patient is getting the actual drug being tested or simply a placebo. Kramer pointed out that people facing a life-threatening illness like AIDS would lie if they had to in order to get hold of a promising treatment.

Cutting to the chase in his inimitable way, Kramer raised a challenge to the FDA: "We're willing to be guinea pigs, all of us," he thundered. "Give us the fucking drugs!"

The AIDS Coalition to Unleash Power, best known as ACT UP, was formed in response to Kramer's fiery speech. ACT UP held its first demonstration a week later -- five days after AZT's approval -- protesting the $10,000 price tag the drug manufacturer, Burroughs Wellcome, had slapped on AZT. Developed with taxpayer-funded research, AZT at the time became the most expensive drug in history.

At the Wall Street demonstration, ACT UP distributed thousands of copies of an op-ed article by Larry Kramer that had run in the New York Times the previous day. "There is no question on the part of anyone fighting AIDS that the FDA constitutes the single most incomprehensible bottleneck in American bureaucratic history," wrote Kramer. "Double-blind studies were not created with terminal illnesses in mind," he noted, calling for the FDA to make experimental AIDS drugs available on a "compassionate usage" basis.

Among ordinary citizens infected with or at risk for HIV, the availability of a drug that had even some promise for treating the virus was the catalyst for a political movement focused largely on pushing for the speedy approval and availability of new drugs to treat HIV and its attendant infections. As Peter Arno and Karen Feiden observe in Against the Odds, "The approval of AZT seemed to unleash a potent force into the world. Patient empowerment -- the refusal to be passive victims, the insistence on fighting the system that would pronounce their doom, the willingness to take matters in their own hands -- became a reality."

In response to ACT UP's demands, FDA Commissioner Frank Young in June 1987 announced the agency's new regulations allowing the use of investigational new drugs (IND) to treat AIDS even as they were being studied in clinical trials. The treatment IND, as it was known, allowed patients to receive drugs that were safe and possibly effective while the companies testing them completed controlled trials and compiled, analyzed, and prepared study data for presentation to the FDA. Unfortunately for people with HIV/AIDS at the time, the flood of new drugs that activists presumed were stuck in the research pipeline simply didn't exist. In fact, AZT would remain the only FDA-approved treatment for HIV infection until 1991.

ACT UP in October 1988 insisted nevertheless that the FDA shorten its drug approval process to "ensure immediate free access to drugs proven safe and theoretically effective," eliminate double-blind placebo trials and instead measure new drugs against other approved or experimental drugs, and "include people from all affected populations at all stages of HIV infection in clinical trials." ACT UP contended that in the case of a new disease like AIDS, the testing of new drugs itself was a form of health care -- and that everyone should have the right to receive health care."

Eight days after ACT UP made its demand, the FDA announced new regulations to speed up the drug approval process, formalizing the expeditious process that had been used the previous year to move AZT quickly through the pipeline to market.

AIDS activists went even further, pushing the federal government to support innovative community-based research programs that tested experimental drugs in doctors' offices rather than in traditional university hospital settings. After AZT became available, doctors participating in the County Community Consortium (CCC) in San Francisco designed a clinical drug trial to study aerosol, or inhaled, pentamidine, a drug that had showed promise in preventing pneumocystis carinii pneumonia (PCP) -- then the leading killer of people with AIDS. In New York, the People with AIDS (PWA) Coalition organized the Community Research Initiative. Larry Kramer called it "an historic attempt by the gay community to test drugs on ourselves." The goal of CRI's founders -- PWA activists Michael Callen and Tom Hannan, their physician Joe Sonnabend, and Mathilde Krim, the founding director of the American Foundation for AIDS Research (amFAR) -- was, as Callen described it, to conduct "rigorous scientific research on promising AIDS therapies in a community-based setting faster and more cheaply than traditional systems do.

On May 1, 1989, Lyphomed, the drug company that held the patent on pentamidine, presented data from the CCC and CRI studies to the FDA. Physician-researchers from the CCC in San Francisco spoke about the effectiveness of inhaled pentamidine, and speakers from New York's CRI offered additional information about the drug's safety.

In a final, personal plea, Michael Callen told the FDA committee, "I have witnessed firsthand the tremendous, unnecessary suffering caused by PCP -- people with AIDS gasping for breath, twitching on respirators, unable to speak." He noted that, despite the desperate need for prophylaxis against pneumocystis and the promise that inhaled pentamidine had showed when used by physicians, "No one in the AIDS establishment seemed to have any interest in the clinical observations of the physicians on the front lines of this epidemic." As was the case with the buyers clubs -- the club in Dallas was only one of the groups that had been organized to support the efforts of people with AIDS to access anything that might work -- Callen said, "The AIDS community has done an end run around federal incompetence and indifference."

Addressing the matter of whether care and research are mutually exclusive categories, the House of Representatives Committee on Government Operations noted in a 1988 report, AIDS Drugs: Where Are They?, that in conducting research on cancer, the federal government had no problem resolving this conflict. "HIV infection," said the report, "may have brought us to the time when it is necessary to reevaluate the dichotomy between research and treatment for all life-threatening conditions." It further stated, "In the context of AIDS and other life-threatening conditions, clinical trials cannot be considered solely scientific experiments. Access to clinical trials becomes access to therapy, access to quality health care, and for many, access to hope."

Hope. That is what Colorado's right-to-try law offers to people with life-threatening illness. It's not a left vs. right issue; it's a basic human need. As for history, it's something with which those dismissing such laws as part of a right-wing and corporatist agenda need to better acquaint themselves.