News about mortalities are rare during a clinical trial, mainly during the initial stages. But in January 2016, six men in France who had enlisted in a phase I trial of a pain relief drug suffered brain damage. One man succumbed.
The report was sidelined saying a coincident.
According to the FDA, there were no clinical trials of the drug in the United States, That does not mean, however, that the U.S. industry won’t feel blow back from the incident that happened thousands of miles away. Indeed, learning from past experiences, the scandal could prompt the FDA to tighten regulations.
In the meantime, FDA regulators began working with their French counterparts in the Agence Francaise De Sécurité du Médicament et des Produits de Santé to apprehend what happened to the six men who signed up to test the drug, goes by the name BIA 10-2474.
A History of Scandals
The last major phase I clinical trial catastrophe in Europe occurred a decade ago in London when six men suffered permanent organ damage, and the loss of fingers, sue to some severe immune reactions during the testing of an arthritis and cancer drug,as per reports.
The main reason of a clinical trial is to give proof to authorities that a drug is safe and effective when used as recommended. Fact is that, many experimental drugs never make a pass through the first stage despite years of testing.
Gagnon said that the French equivalent, the Agence Francaise De Sécurité du Médicament et des Produits de Santé, abbreviated as ANSM, is a very genuine and sophisticated regulatory body. French clinical research organizations have to follow the country’s domestic rules and regulation programs as well as international and European Union regulations. Gagnon added that France and other EU countries are no different from the United States in requiring organizations to conduct proper clinical researches that will be safe for participants. The FDA basically conducts more inspections of sites, manufacturing facilities, labs and companies, mainly because FDA regulators have more resources to do so.
One of the most infamous scandals happened half a century ago and involved a sedative, thalidomide, which caused severe malformations among babies whose mothers took the drug to do away with morning sickness.
Thalidomide, yielded by a West German company and marketed in 46 countries, never made it to U.S. consumers. Frances Kelsey, a FDA drug reviewer said that in next to no time the fighting over the new drug laws that had been going on for five or six years suddenly melted away.
That scandal added another dimension to the review process, according to an account by FDA historian Suzanne White Junod. After thalidomide, drug manufacturers not only had to prove that a drug was safe, they also had to show “substantial evidence” that the drug was effective based on “adequate and well-controlled studies.”
Balancing Risk and Rigor
Today the scale of approval of new therapies has become very high. The FDA holds patient safety as foremost in their review decisions,which helps pharmaceutical and medical device companies meet safety regulations.
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