Did Controversial AZT Treatment Kill More Patients than AIDS in ’80s, ’90s?

Commonly called AZT, azidothymidine was originally produced to treat cancer two decades prior to the HIV epidemic.

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Key Facts:

  • Dr. Anthony Fauci, who has been the director of the National Institute of Allergy and Infectious Diseases at the National Institute of Health since 1985, led efforts to find a treatment for AIDS at the onset of the epidemic throughout the 1980s. One such treatment was azidothymidine, commonly called AZT, which was created decades earlier as a cancer treatment but shortly shelved for its high toxicity and adverse side effects.
  • However, there is no evidence to suggest that the administration of AZT killed more people than the virus itself. 
  • It is unknown how many — if any — deaths resulted directly from patients being treated with AZT, as early testing was not always standardized to account for various other experimental and approved treatments, as well as from infection by HIV or other secondary illnesses.

As the COVID-19 pandemic neared its second year in the fall of 2021, misinformation targeted at denouncing leading health officials and questioning the integrity of their decisions continued to circulate the internet. One man consistently at the center of such claims was Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases at the National Institute of Health since 1985. 

In September, memes shared widely on Facebook and sent to our staff claimed that at the beginning of his career — which coincided with the onset of the AIDS epidemic — Fauci promoted a controversial treatment called azidothymidine, commonly known as AZT. To discredit the doctor, one such meme claimed that more people died from AZT than did from HIV, the virus that causes the immunodeficient disease. 

A still image of a young Fauci appearing to speak on C-SPAN is pictured next to text that read, “Remember that one time in the 80’s-90’s when people died from the AIDS treatment (AZT) and not the actual AIDS virus? Remember that one doctor [Fauci] who promoted that treatment?” The implication was that Fauci was responsible for these alleged deaths. The most lurid versions of this claim declared that Fauci “killed” or “murdered” AIDS patients by promoting AZT treatments. 

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Though some basic elements of the claim are true (more on that later), the allegation lacks not only evidence but broader context and a deeper understanding of both the AIDS epidemic and the fast-tracked approval processes meant to quickly find a safe and effective treatment for the newly discovered disease. And while it is true that Fauci was at the NIH in the beginning years of the epidemic and that he played a role in such research, it is misleading to allude he alone is responsible for approving the treatment. 

Furthermore, there is no evidence to suggest that the administration of AZT killed more people than the virus itself. It is unknown how many — if any — deaths resulted directly from patients being treated with AZT as early testing was not always standardized to account for various other experimental and approved treatments, as well as from infection by HIV or other secondary illnesses. Today, AZT is still one of more than 30 therapies approved in the United States for the treatment of AIDS. 

Origination of the Claim

The meme appears to have sourced information from a 1989 article published in the music magazine Spin, as first reported by the non-profit science education organization Health Feedback. A 2015 digital reprint of the article included an introduction by magazine founder Bob Guccione Jr., who described the “truly bad and corrupt science surrounding promoting AZT as a treatment for the syndrome of diseases.” 

The 1989 article, Guccione continued, “unearthed hard evidence of the cold-bloodedness of the AIDS establishment pushing a drug that was worse than the disease, and killed faster than the natural progression of AIDS left untreated” — both claims that are erroneous. Among other assertations, the article argued that thousands had been “walloped” with high doses of AZT and “possibly even died of toxic poisoning.” 

But the original article was written in 1989, and in the decades that followed, researchers would deepen their understanding of proper dosing requirements for AZT and how it could be used in combination with other therapies to effectively treat AIDS. 

Dr. Anthony Fauci examining an early AIDS patient at NIH in 1987. Public Domain/NIAID
 

A Look Back at the AIDS Epidemic

On June 5, 1981, the Centers for Disease Control and Prevention (CDC) published a report of five cases of Pneumocystis carinii pneumonia among previously healthy gay men in Southern California — two of whom had died. Those cases described a mysterious unknown disease that attacked the immune system and would later be recognized as the first known occurrences of AIDS. At the time, a diagnosis with the disease was considered a death sentence. During the first decade of the epidemic, the NIH estimated that the average life expectancy was one year, prompting global health leaders to race for treatment.

At the time of the AIDS epidemic, FDA approval and testing typically took between eight and 10 years and patients couldn’t wait that long. In 1984, scientists discovered AIDS caused by retrovirus HTLV III, which would later be called HIV. The virus attacks and destroys white blood cells known as CD4 T-lymphocytes, or T-cells, to a point where the immune system can no longer respond and combat infections otherwise harmless to healthy individuals.

Through a drug screening initiative launched in the fall, the British pharmaceutical company Burroughs-Wellcome found evidence that AZT could suppress viral replication in mouse studies. At the same time, scientists at NIH led by Oncologist and Clinical Researcher Dr. Samuel Broder at the NIH National Cancer Institute (NCI) used live HIV to develop tests that could determine how effective certain compounds were against HIV in humans using T-cell clones. In Fall 1984, Burroughs Wellcome contacted Broder, who agreed to accept AZT compounds to test on HIV.

In February 1985, Broder would later write that testing showed AZT suppresses HIV replication in culture dishes and did not damage the viability and function of normal cells. When used alone, AZT was found to decrease death and opportunistic infections in AIDS patients. By July, the first patients would be enrolled in the AZT Phase I trial; a Phase II randomized, placebo-controlled study of AZT efficacy in AIDS patients would begin in February of the next year (more on that controversial study later).

By September, the Phase II trial was halted after patients treated with AZT were found to have a “significantly higher” survival rate than the placebo group. The following month, AZT was made available for patients at the request of their doctor.

On March 19, 1987, the FDA formally approved marketing the new drug for AIDS treatment in a record 107 days — still among the fastest approval tracks today.

“Given the urgent need for therapy, we approved the drug based on evidence from only one clinical trial in humans and that trial was stopped after 19 weeks because patients taking the placebo were overwhelmingly dying faster than those given the drug, and continuing the trial would have been unethical. Many of today’s regulatory tools used by the FDA for expediting review of critical drugs stem from the approvals of early HIV therapies,” wrote the U.S. FDA.

That same year, clinical trial ACTG 016 established that a lower therapeutic dose of AZT reduced some side effects. The subsequent ACTG 019 trial showed that the drug could delay the onset of AIDS in asymptomatic people with HIV.

An open uncontrolled study on treatment study published in 1989 showed that the median survival time of AIDS patients on AZT was 4.5 times higher when compared to historical AIDS groups who had not received the drug.

Throughout the early 1990s, additional NRTI drugs gained approval, showing that along with AZT, other therapeutic drugs were effective at treating AIDS. In 1991, an asymptomatic Magic Johnson made headlines when the basketball legend began a treatment of AZT following a recent AIDS diagnosis, The Washington Post reported at the time. In an interview with CNN nearly three decades later, Johnson credited his early intervention and quick course of treatment with following scientific recommendations. 

AZT was the first drug approved by the FDA to treat AIDS. Public Domain

What Is AZT? 

AZT belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Scientists funded by the NCI developed azidothymidine in 1964 as a potential treatment for cancer and while the drug showed promise at stopping tumor cells from replicating, the drug was deemed largely ineffective and shelved for decades. 

Part of what makes HIV so difficult to treat is the virus’ ability to quickly mutate, causing small changes in the virus that help it to resist antiretroviral drugs. And when it came to AIDS, AZT was shown to halt one of the early steps of the HIV life cycle by blocking an enzyme called reverse transcriptase, which assists in the virus’ ability to make copies of itself. 

A Fast-Track Approval Rife with Controversy

The 1987 research, which was published in the New England Journal of Medicine, ultimately led to the approval of AZT. This double-blind, placebo-controlled study aimed to test the efficacy of AZT in 282 patients diagnosed with AIDS or AIDS-related complex. Of them, 145 people were given AZT and 137 the placebo for a total of 24 weeks. 

In the end, only 27 subjects had completed the full course of the study (others ended at 16 and eight weeks) after 19 placebo recipients and one AZT recipient died during the study. 

Researchers argued that it wouldn’t be ethical to continue with the trial knowing that those who took AZT had such a significantly higher rate of survival. The data, they argued, suggested that AZT can “decrease mortality and the frequency of opportunistic infections” over at least the course of eight to 24 weeks. But as Time reported, controversy abounded the study. Scientists were not able to standardize a course of treatment for secondary infections across participants, nor were they able to control for other variables. 

Other questions lingered: could those who weren’t sick still benefit? At what stages in the disease was AZT no longer effective? And as Spin reported, both the study participants and researchers were not fully blind to the study: 

Both sides contributed to the unblinding. It became obvious to doctors who were getting what because AZT causes such severe side effects that AIDS per se does not. Furthermore, a routine blood count known as a CMV, which clearly shows who is on the drug and who is not, wasn’t whited out in the reports. Both of these facts were accepted and confirmed by both the FDA and Burroughs Wellcome, who conducted the study.

Many of the patients who were in the trial admitted that they had analyzed their capsules to find out whether they were getting the drug. If they weren’t, some bought the drug on the underground market. Also, the pills were supposed to be indistinguishable by taste, but they were not. Although this was corrected early on, the damage was already done. There were also reports that patients were pooling pills out of solidarity to each other. The study was so severely flawed that its conclusions must be considered, by the most basic scientific standards, unproven.

Regardless, the study meant that AIDS was treatable, launching the way for other therapies to be studied.

“I was also willing to accept that it is better to make some progress quickly than hold back and wait for a cure before acting or before trying to implement a new therapy,” said Broder in a 1997 interview.

“A starving man or woman cannot turn down a slice of bread because it is not a full loaf, and I think that, on balance, many of the scientists involved, perhaps from a combination of well-intentioned but naive analyses of the situation, were really saying, ‘A cure or nothing. Give me 20 years and I’ll give you a cure.”

Just like chemotherapy, the drug is toxic but the benefits of stopping the virus were dubbed to outweigh the consequences of allowing the virus to run its course. 

“AIDS was a public health emergency, and it was essential to get things started. AZT is out there. It is an approved product. I view that as a successful example of a public/private collaboration. It laid the foundation for almost every other product because, in my view then and now, the failure of AZT would have had very dramatic effects,” said Broder. 

“The AZT collaboration stimulated a lot of science, and laid the foundation for better drugs in the future. And it also provided patients with a measure of hope, at a time when there was none.” 

AZT served has since been called the “prototype” for AIDS treatment and is considered a “first step” in the AIDS response, establishing standards and an understanding of viral suppression. 

From a Death Sentence to a Manageable Condition 

In the three decades since its discovery, AIDS went from “inherently untreatable” to a chronic, manageable condition treated through a range of therapeutics. In 2021, there are more than 30 drugs designed to block viral replication at different stages of its life cycle — one such being Retrovir, the market name for AZT. A CDC report analyzing reported AIDS cases from the first reported case in the U.S. in June 1981 to Dec. 31, 2000, showed that 774,467 people had been diagnosed with AIDS in the U.S. Of those, 448,060 had died. 

“Some people had hoped that AZT would be a cure. No one at NIH ever said that it would be. And, therefore, when it was not a cure, that reality affected people. And then there was the overreaction the other way,” said Broder in that same 1997 interview.

“There is, to this day, a group of individuals who argue that HIV is not the cause of AIDS. They argue that the NIH has not been telling the truth. The capacity of antiviral drugs to prevent premature deaths and alleviate suffering in patients with AIDS, to block the transmission of the AIDS virus from mother to unborn child, and a host of other scientific observations, can mean only one thing.”


See other examples of Fauci claims we have debunked here See other examples of Fauci claims we have debunked here:

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