By Robin Brodrick
This post is continued from the post: The History of Clinical Research: 1950 – 1980.
The History of Clinical Research: 1980 – 2009
1981: Immunodeficiency first reported in gay men in Los Angeles, New York City, and San Francisco
On June 5th, 1981, the Morbidity and Mortality Weekly Report reported five cases of Pneumocystis carinii pneumonia (PCP) in Los Angeles. These cases occurred in young men who had previously been healthy. Two of the five men died. The case histories suggested that the contraction of PCP was brought on by a “disease acquired through sexual contact” and a “cellular-immune dysfunction related to a common exposure”. The report provoked supplementary case reports in New York City and San Francisco, among other cities. 18 months later, epidemiological studies had been conducted and all major risk factors for acquired immunodeficiency syndrome (AIDS) had been identified. However, the cause of the illness was still unknown. In 1983, the CDC announced guidance for the prevention of the disease.
1982: Chicago Tylenol murders
In October of 1982, seven people died after taking Extra-Strength Tylenol capsules that had been laced with potassium cyanide. Investigators were able to determine that the culprit acquired the bottles from drug and grocery stores, added the poison to the capsules, and then placed the bottles back on the shelves of the stores. A total of eight bottles were found that had been tampered with. Later, tests would show that the capsules contained ten times the amount of cyanide needed to result in death. Johnson & Johnson (J&J) immediately stopped production, ceased advertising, and issued warnings to distributors and hospitals. Police cars also drove around the Chicago area and made announcement warnings. J&J handled the crisis so well that media across the country gave them accolades for their actions. This crisis resulted in federal anti-tampering laws and reforms in the packaging of over-the-counter (OTC) substances. So, the next time you fervently struggle to open the tamper-proof seal on a bottle of OTC medication, just remember the Tylenol scare that resulted in the deaths of seven unsuspecting people.
1983: Orphan Drug Act
In 1983, the Orphan Drug Act was passed to encourage manufacturers to develop treatments for rare conditions and diseases. Drugs for rare disease and conditions are commonly called orphan drugs. Congress found that there are many rare diseases such as Lou Gehrig’s disease (ALS), Huntington’s disease, and muscular dystrophy that can be considered rare in the United States because they affect such a small population of its residents. Unfortunately , adequate drugs for many rare conditions and diseases had not been developed because pharmaceutical companies would not sell enough of the drug to cover the development cost. Congress made changes to the Federal laws to reduce the cost and to provide financial incentives to companies that developed orphan drugs. These changes included tax incentives and allowing drugs to be sold without competition for seven years. Prior to the Orphan Drug Act, only ten drugs were developed in ten years. After the Orphan Drug Act, 41 FDA approved drugs were developed in 25 years.
1990: Human Genome Project is launched
Planning for the Human Genome Project (HGP) began in 1984. The project itself began in 1990 and was completed in 2003. The HGP was an international scientific research project. Its goal was to map the more than three billion nucleotides in a human haploid reference genome. About ten percent of the total genome remains unmapped because the project did not study the entire DNA found in human cells. The benefits of this project began to emerge before the project was completed in the form of genetic testing that could identify a predisposition to many illnesses like various forms of cancer, cystic fibrosis, and many other sever diseases. Scientists can also visit the HGP online to see what other researchers have noted about particular genes, which could help molecular biologists develop new therapeutic procedures in the future.
1992: FDA Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) was passed by Congress in 1992. It requires drug manufacturers to pay application fees every time they file a Biologics License Application (BLA) or New Drug Application (NDA). The fees are used to fund drug approval activities in the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER).
1994: Veristat is born & Clinton Administration declassifies human radiation studies
As discussed in the previous posts in this series, it was common practice for physicians to conduct research without getting a patient’s consent first. In January of 1994, President Bill Clinton and an Advisory Committee investigated the human radiation experiments that were conducted after World War II and into the Cold War. The Committee discovered that in many of the experiments there was no scenario where the patient could benefit, such as the patients who were injected with plutonium, uranium, or mind altering drugs. Many of the records from these studies had been destroyed. However, the Clinton Administration did declassify all records that could be found.
Veristat was also founded in 1994. You can learn Veristat’s founding story in the post Everything You Wanted to Know About Veristat but Were Afraid to Ask, and can learn about Veristat’s future in the post Veristat’s Vision of the Future.
1997: FDA Food and Drug Administration Modernization Act
The Food and Drug Administration Modernization Act (FDAMA) brought about the most widespread reform in FDA practice since the Federal Food, Drug, and Cosmetic Act of 1938. The act included measures to increase patient access to experimental drugs and medical devices, harmonize regulations, regulate advertising, and accelerate (i.e. fast track) the review time for the approval of drugs from 30 months to 15 months.
1999: Jesse Gelsinger dies
Jesse Gelsinger was the first gene therapy clinical trial participant to be publicly identified as having died as a result of the trial. Gelsinger was only 18 years old at the time of his death, which was caused by a massive immune response triggered by the use of a adrenal vector that was used to transport a corrected gene into his cells. The theory was that this would prove the effectiveness of gene therapy for ornithine transcarbamylase deficiency, an X-linked genetic disease of the liver. Unfortunately, it lead to multiple organ failure and brain death for Gelsinger. When the FDA investigated, they discovered that the scientists involved in the trial had disregarded several rules of conduct, including the failure to disclose the deaths of three monkeys as a result of the treatment in the informed-consent documentation. The Gelsinger case was a serious setback for gene therapy scientists.
2001 – 2009: Stem cell research regulations
In 1999, the Clinton Administration made it legal for the study of Human Embryonic Stem Cells (hESC) to be eligible for federal funding. The caveat was that the embryos could not be created for the sole purpose of experimentation, but instead had to come from embryos that were discarded after in vitro fertilization treatments. In 2001, the Bush Administration signed an order that prevented the National Institutes of Health from funding embryonic stem cell research beyond the 60 cell lines that already existed at that time. President Obama repealed Bush’s policy in an executive order signed in 2009.