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.
The meme appears to have sourced information from a article published in the music magazine Spin, as first reported by the non-profit science education organization Health Feedback. A digital reprint of the article included an introduction by magazine founder Bob Guccione Jr. But the original article was written in , 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.
On June 5, , 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.
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. In February , 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.
The following month, AZT was made available for patients at the request of their doctor. On March 19, , the FDA formally approved marketing the new drug for AIDS treatment in a record days — still among the fastest approval tracks today. Limited baseline characteristics were presented by the authors.
Presented as an average of both groups except where stated. Comparisons are zidovudine vs. Of note, the authors state that no difference in the rate of OIs existed until after 6 weeks of therapy. At that point, individuals in the zidovudine group no longer developed OIs. The authors comment that patients were more likely taken off the study if they had very low CD4 counts, likely influencing the outcome of the AIDS-related complex findings at 24 weeks. In December , saquinavir became the first protease inhibitor to receive FDA approval.
This study found that a three-drug combination of the protease inhibitor indinavir and two NRTIs reduced viral loads to very low levels for up to one year in people who had previously been taking single-drug therapy. ACTG also showed that adding at least two new drugs when switching therapy is more effective than adding a single new drug. The side effects were burdensome, and the daily dosing was complex.
Certain drugs had to be taken in combination at different intervals throughout the day, some with food and some without. The complexity made it difficult for people to adhere to the regimens long-term. To address the complexity of antiretroviral regimens, drug toxicities, and the issue of drug resistance, NIAID supports research aimed at novel formulations and development of drugs that work by different mechanisms and target various steps in the HIV replication process. Currently, more than 30 antiretroviral drugs are available, including several fixed-dose combinations, which contain two or more medications from one or more drug classes in a single tablet.
Today, many people control their HIV by taking as little as one pill once a day. Access an infographic comparing antiretroviral therapy in the s and today.
The mids marked the emergence of another new class of antiretroviral drugs called non-nucleoside reverse transcriptase inhibitors or NNRTIs. Because they are cheaper and easier to produce than protease inhibitors, they helped scale up antiretroviral therapy in resource-limited settings.
Identification of novel drug targets has played a key role in discovery and development of new antiretroviral drug classes. For example, since the s, scientists have known that a molecule called CD4 is the primary receptor for HIV on immune cells.
This discovery inspired researchers to look for other co-receptors. This work laid the foundation for the development of the CCR5-blocking drug maraviroc, which received FDA approval in Another major antiretroviral drug class emerged in , with FDA approval of the integrase inhibitor raltegravir. Raltegravir quickly became a valued component for combination antiretroviral therapy, but HIV can follow several pathways to develop resistance to the drug.
HIV variants resistant to raltegravir may also be resistant to elvitegravir, another first-generation integrase inhibitor. Dolutegravir, which received FDA approval in , is a second-generation integrase inhibitor that appears to have a high barrier to the development of HIV drug resistance. In clinical trials, dolutegravir was effective both for people living with HIV who had not previously taken HIV therapy and for people who were treatment-experienced, including those for whom first-generation integrase inhibitors were ineffective.
Additional advantages of dolutegravir include convenient once-daily dosing, a good safety profile, and a relatively low production cost. Dolutegravir now is included in two of the first-line regimens that the U. Department of Health and Human Services medical practice guidelines recommend for adults with HIV, and it was recently added to World Health Organization guidelines as an alternative first-line agent for adults.
NIAID continues to support work to develop new antiretroviral drugs and new tools to improve HIV treatment, such as long-acting therapies that may serve as alternatives to daily antiretroviral therapy.
Skip to main content. Skip to Back. Search for Resources. Division of Intramural Research Labs. Research at Vaccine Research Center. Clinical Research. Infectious Diseases. Resources for Researchers. Managing Symptoms. Understanding Triggers. Autoimmune Diseases.
Disease-Specific Research. Characterizing Disease. Researcher Resources. Dengue Fever. Shiga Toxin-Producing E. Researching Ebola in Africa. Photo Essay. Food Allergy. Research Approach. In fact, such symptoms could frequently be ameliorated if their causes were aggressively sought. More often than not they were caused by treatable conditions. I and other community physicians aggressively tried to establish the cause of such symptoms.
It was the experts who in fact were more likely to attribute them to AIDS and therefore consider them to be untreatable. The provision of general support, including attention to nutrition and mental health and other issues are parts of patient management. This is pretty labour intensive doctoring, but these measures were able to prolong the lives of our patients. Needless to say, it was community doctors who had to develop such strategies without much help from the experts.
I believe the first recommendations on patient management made by the medical authorities leading the response to the epidemic were those concerning prevention of pneumocystis pneumonia in It took place in 12 centers across the country.
There was no uniform approach to patient management during the trial; each of the 12 medical centers determined this independently. So the most important series of measures determining life or death in the short term was left unspecified. I suppose one has to conclude that government medical experts, unlike community doctors, must have felt that nothing could be done for people with AIDS, that the only hope to be found was in a new drug.
So if in the short term patient management strategies can make the difference between life and death is there any reason to consider that such strategies may have differed in those receiving placebo or AZT? The reason why randomized placebo controlled clinical trials are blinded, so that neither investigator nor participant knows who is receiving placebo or active drug is to minimize bias.
Bias can influence the outcome that might incorrectly be attributed to a drug effect. The drug causes changes in routine blood counts that investigators need to see. Therefore we must conclude that investigators could know who was receiving AZT or placebo. If patient management is the most important determinant of mortality in the short term, could bias have influenced the ways patients were managed? Patients known to be taking AZT or placebo might have unintentionally been treated differently, with either greater or lesser care, when the investigator was also the treating physician.
AZT may therefore have been even more effective than claimed or may have been worse. In some centers were there instances where the participant also had a personal physician? If this occurred, as is likely to be the case, there was no analysis of trial outcomes based on this compared to centers where the study physician was also the treating physician. There was also no analysis of outcomes by study center. New York City was a study site. Were patients referred to the study site at St Lukes Roosevelt Hospital Center by personal physicians who continued to care for their patients?
Information must still be available regarding mortality at different study centers, and in relation to whether the participant was treated by the study doctor or had a personal physician.
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