FDA revises methods, after public outrage at testing of monkeys

pharmafile | January 29, 2018 | News story | Manufacturing and Production, Medical Communications FDA, biotech, drugs, pharma, pharmaceutical 

The story broke in September of last year that the FDA was testing nicotine addiction in squirrel monkeys and that four had died as a result of their treatment at the hands of the agency.

The FDA announced that it would suspend the trial, at the time, before finally reaching the decision that it would cancel the experiment altogether.

The testing was instigated to determine how various levels of nicotine in young monkeys could provide clues as to how addiction develops in adolescents and young adults.

However, after the deaths of four monkeys, a damning open letter from Dr Jane Goodall, a world-renowned primatologist, highlighted the disturbing treatment of the animals and brought even greater public attention to the case. A part of the letter read, “Not only is it extremely cruel to restrain the monkeys, but the ill-effects of the nicotine, apparently recorded on video and documented, are said to include vomiting, diarrhoea and tremors. I was especially horrified to read that during the course of these experiments, each monkey is locked alone in a cage for nearly three years. For such social and intelligent animals this, together with the horrific experiments themselves, is tantamount to taxpayer-funded torture”.

In response, Scott Gottlieb, FDA Commissioner, announced that the agency would reform its practices and immediately terminate the program, sending the remaining monkeys to a permanent sanctuary home.

He announced that the FDA will establish a new Animal Welfare Council to provide oversight on animal research whilst implementing a third-party review of the agency’s animal research programs.

However, he reiterated the reasons for which the agency believes animal testing is essential to achieve breakthroughs in science: “Without animal research, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. In the past, animal research has played a critical role in vital health advancements such as preventing polio, eradicating smallpox and identifying new cancer treatments. Further, there are still some areas for which non-animal testing is not yet a scientifically valid or available option. For example, animal research with primates continues to be an essential part of the safe and effective development of certain critical childhood vaccines.”

One of the major criticisms of the study were that, in this case, there was little need to test monkeys for addiction to nicotine, given that there are plenty of studies regarding human addiction.

Ben Hargreaves

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