News

8 July 2020

By Nicole Ellenrieder

From Tragedy Came Progress

– Takes 6 minutes to read this topic –

In the early 20th century, the scientific community advocated for the use of “well-controlled” therapeutic drug trials. These relied on laboratory analysis followed by clinical testing in animals and humans. But the development of these drug trials was helped along by some of the darkest episodes in the history of (bio-) pharmaceutical and medical research.

Elixir Sulfanilamide and the Food Drug and Cosmetics Act

In 1938, the U.S. Food, Drug, and Cosmetic Act (FDCA) was enacted, requiring all new drugs to be tested for safety and efficacy prior to approval for marketing. The law, still in force today, replaced the U.S. Pure Food and Drug Act of 1906 and was adopted within six months of the Elixir Sulfanilamide tragedy. This tragedy killed more than a hundred people prescribed a liquid preparation of sulfanilamide, a synthetic antibacterial used to treat Streptococcal infections, using diethylene glycol (DEG), a chemical cousin of antifreeze, as a solvent. The incident became known as one of the most consequential mass poisonings of the 20th century. Although the manufacturer, claimed that a thorough and complete clinical trial program had been conducted to validate the safety and efficacy of the drug before putting Elixir Sulfanilamide on the market, the FDA later determined that there had been no clinical trials nor a “post-marketing” study.[1]

The FDCA, enacted shortly after the disaster, for the first time gave FDA regulators the tools and authority to review both pre-clinical and clinical test results for new drugs. While the law did not specify the kinds of tests required for approval, the act authorized the FDA to formally block or delay marketing approval of a new drug by requiring additional safety data. Under the FDCA, regulators also received powers to negotiate the rigor of scientific studies with the pharmaceutical industry and drug developers. However, this authority did not allow them to regulate clinical trials. Following WWII, randomized, controlled clinical trials became a critically important part of modern drug development.

The Thalidomide Crises

Sleeplessness was a prevalent medical issue diagnosed in the post-war years and one in seven Americans frequently reached for tranquilizers and sleeping pills. In some European countries the demand for sedatives was even higher.

In 1957, thalidomide entered the German market as a safe, over-the-counter remedy. The drug was originally marketed as treatment for insomnia, coughs, colds, and headaches. Without clear safety data the manufacturer of the drug, the German company Chemie Grünenthal GmbH, convinced regulators and doctors that thalidomide, marketed as Contergan, was also an effective antiemetic that had an inhibitory effect on morning sickness. Despite the fact that the drug had never been tested on pregnant mammals and was chemically similar to drugs known to harm embryos, it was advertised as “completely safe” for everyone, including mother and child, “even during pregnancy.” [2][3]

Once doctors recognized that thalidomide caused congenital deformities resulting in shortened, absent, or flipper-like limbs, the manufacturer finally stopped distribution in Germany. Other countries followed suit and by March of 1962 the drug was banned in most countries where it had previously been sold.

The thalidomide tragedy led to the development of the rigorous drug approval and monitoring systems we know today. With the passing of the Kefauver-Harris Drug Amendments Act of 1962, legislators tightened restrictions surrounding the surveillance and approval process for drugs to be sold in the United States, requiring manufacturers to demonstrate that they are both safe and effective before receiving marketing authorization. As a result, drug approval today takes, on average, between eight and 12 years, involving animal testing and tightly regulated human clinical trials, requiring more attention to clinical trial design, and resulting in more clinical data to be analyzed.

Today, trial designs and the collection of increasing amounts of clinical data are facilitated through enabling technologies. XClinical’s Marvin all-in-one e-clinical platform helps clinical trial teams protect their valuable data assets. Our professional services team adds the right mix of professional study setup, consulting, and training services – from “full-service” to “do-it-yourself” – to meet your specific needs. Contact us today to learn more about our offerings.

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[1] “Medicine: Post-Mortem.” Time, Monday, December. 20, 1937. Online. http://content.time.com/time/magazine/article/0,9171,758704,00.html Last accessed October 17, 2019], [2] “Thalidomide: A History.” Onco’Zine. Online. [3] “Medicine: The Thalidomide Disaster.” Time, Friday, Aug. 10, 1962. Online. http://content.time.com/time/magazine/article/0,9171,873697,00.html Last accessed October 17, 2019.

Image Credit:  kieferpix / iStock.com

Nicole Ellenrieder

Hello, I'm Nicole Ellenrieder

Global Head of Project Management

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