The HIV/AIDS epidemic has affected over 78 million people worldwide in the past 34 years. In commemoration of those still living with AIDS, PharPoint invites you to examine an AIDS timeline of events in the United States.
t has been said that a smooth sea never made a skilled sailor – and if anything requires great skill, it’s working in pharmaceuticals. The pharmaceutical industry has weathered great challenges throughout the years and continues to stand tall.
A classic example is the outbreak of HIV/AIDS, a disease that spread quickly and sent shockwaves across the globe. Undoubtedly one of the largest obstacles ever presented to the pharmaceutical industry, HIV/AIDS demonstrated the effectiveness of the drug development process – and helped to breed the next generation of fierce and dedicated pharma workers.
From Phase I through Phase IV, clinical trials require special attention and expertise to ensure that only the best and most effective medications make it onto shelves. When there is an epidemic on the loose, this process can be hectic – and, therefore, requires clinical research organizations (CROs) and drug developers with years of experience in the industry, navigating the FDA’s regulations. With a team of seasoned industry veterans and thought leaders, PharPoint exemplifies such a CRO.
The world recently observed the 34th anniversary of the first diagnosed cases that sparked the HIV/AIDS epidemic. In honor of World AIDS Day on December 1st, PharPoint invites you to examine an AIDS timeline of events in the United States.
Immunodeficiency As a Medical Mystery
To begin examining the AIDS timeline of events, we must go back to when this disease began as a medical mystery. In early June 1981, the U.S. medical community was puzzled by the unique cases of five men, all reported with a very rare lung infection. Despite having no preexisting health conditions, each man also experienced additional, seemingly unrelated infections. Unsure of what the diagnosis was, the cases were reported as severe immunodeficiency by the U.S. Centers for Disease Control and Prevention (CDC) later that week. By the time the report was released, two of the five men had already died.
In just a few days, there were reports of similar cases throughout the United States. By the end of 1981, there were 270 cases of – and 121 deaths caused by – severe immune deficiency.
By April of the following year, it was estimated that tens of thousands of people were affected by the mysterious disease. On September 24th, 1982, CDC used the term “AIDS” (acquired immune deficiency syndrome) for the first time. And by the holidays, there was the first hint at the mode of transmission: 22 infants who received blood transfusions had immunodeficiency.
As members of varying demographics contracted the disease (including infants, females, and hemophiliacs), confusion gripped the country. Education is often the most useful tool in the face of public unease; and for this reason, a National AIDS Hotline was established to soothe and inform frenzied Americans.
As the disease became more prominent, specialized healthcare facilities were also established. The first AIDS ward in the United States soon opened at San Francisco General Hospital and was filled to capacity in a matter of days.
Though routes of transmission had been identified, the underlying cause was not determined until 1984, three years after the perplexing cases of those five men. Dr. Robert Gallow of the National Cancer Institute identified a retrovirus that was responsible for the AIDS outbreak. The retrovirus was dubbed HIV (human immunodeficiency virus).
A retrovirus infects a host cell by using RNA to integrate itself into the very DNA of our cells – meaning that as our cells multiply, so do the number of infected cells (and immune system cells replicate quickly, so the virus does too). Scientists have since identified the predominant strain of HIV-1 and have genetically traced the virus back to its origin. Because of this, we now know that HIV originated in a subspecies of chimpanzees in West Africa and was transmitted many years ago to human hunters who were exposed to the infected blood.
HIV/AIDS: Overcoming a Clinical Challenge
Once the disease finally had a determined causality, attention turned towards defeating it. Even though strides had been made to understand the disease, it was rapidly spreading; by 1985, there were AIDS cases reported from each region of the world. AIDS was the leading cause of death in all young Americans by 1994. The need for a cure hung heavy in the air of every hospital and treatment center, and as the numbers kept rising, all those affected by HIV/AIDS became more and more frantic.
In the face of upheaval, the medical community worked with renewed vigor to treat patients as quickly and effectively as possible. Extending the lifespans of HIV/AIDS patients – and improving their quality of life – was a vital mission for the pharmaceutical industry.
This lead to the creation of a new class of experimental drugs, Treatment Investigational New Drugs, which accelerated drug approval by up to three years. Drugs were constantly being tested, recombined, and redeveloped.
For example, the effective medication AZT was fine-tuned and later combined with other drugs as a part of a protease inhibitor called HAART. Combivir, another anti-retroviral combination drug, was also prescribed to reduce the number of medications patients would need to take daily.
Ultimately, these drugs were a resounding success. Largely due to the use of HAART, AIDS-related deaths in the United States declined by 47% in one year. Today, HAART is still the standard of care for HIV/AIDS, and has drastically improved the average lifespan of HIV-positive patients. Antiretroviral therapies have transformed HIV/AIDS from a fatal diagnosis into a manageable disease.
Employees of PharPoint have performed research that continues to improve existing HIV/AIDS treatments and develop new ones. One example is our contribution to the START trials, a large-scale study that tested whether it benefited HIV-positive patients to begin antiretroviral treatment (ART) sooner. An interim review of the trials demonstrated major results: HIV-positive patients who begin taking ART sooner (when their CD4 cell count is at 350 cells/mm³ instead of the current baseline of 500 cells/mm³) have a considerably lower risk of developing AIDS.[bctt tweet=”PharPoint performs research to improve existing HIV/AIDS treatments and develop new ones.”]
But just as important as treatment is prevention. The best way to prevent HIV is to vaccinate against it, and as such, researchers, pharmaceutical companies and CROs continue to work with fervor to develop an HIV vaccine. While the search for a vaccine continues, highly accurate HIV detection tests have been made widely acceptable to slow the spread of the disease.
PharPoint researchers have participated in over 90 HIV/AIDS clinical trials, all of which have contributed to the ultimate goal: eradicating HIV/AIDS for good.
Abundant Hope for the Future: Clinical Outlook for HIV/AIDS
The AIDS timeline we’ve put together demonstrates the strides that have been made through the pharmaceutical development process. Many of PharPoint’s employees started their research careers in HIV clinical trials. Kyle Shotwell, Senior Clinical Project Manager at PharPoint, remembers going straight from learning about the newly-discovered HIV retrovirus in the classroom to seeing it first-hand as a Clinical Research Associate.
He recounts some of the challenges he experienced working on HIV/AIDS clinical trials:
“You have to keep in mind that these were expensive, experimental drugs. Drug hoarding by patients was a huge issue – you’d have patients run out of pills on Day 10 when they were supposed to make it to Day 30. Drug accountability was incredibly important so that we could keep the accessibility of the medicines regulated. And we had to take into consideration that patients in these trials were also almost entirely of underprivileged, lower economic status, so education was crucial to try and minimize the spread of the disease.
It was a real eye-opener compared to my previous field work in anti-bacterial drugs, proton pump inhibitors, and so on – things that didn’t have the same level of desperation for a cure.”
Today, the resources for HIV-infected patients are plentiful. Many government-sponsored programs provide medical, housing, and financial assistance for those affected with the disease. With current treatments, someone living with HIV can enjoy comparable lifespans if the disease is well-managed and medications are taken correctly.
HIV/AIDS has affected millions of people across the globe, and was one of the largest epidemics to challenge modern medicine. The lessons learned from HIV/AIDS clinical trials have provided PharPoint employees with a breadth of knowledge and experience, and have better prepared all pharmaceutical workers for handling future medical mysteries.
While the road ahead is still a difficult one for HIV/AIDS patients and healthcare providers, there is abundant hope. The amount of information and resources available for finding a preventative vaccine is greater than ever before, and with the help of an experienced CRO, any HIV/AIDS clinical trial could be the one to make a major breakthrough in the development of a vaccine.
PharPoint Research has extensive experience in HIV/AIDS clinical trials. Keep the conversation going on social media! Reach out to us on Facebook, Twitter, Google+ or LinkedIn with any questions you have about our AIDS timeline. For more information about our experience and services, feel free to contact us.
To find out how to support World AIDS Day, check out their official website here.