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THE CITY REBORN FROM THE ASHES OF AMERICA'S MOST DISASTROUS FOREST FIRE
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From My Window

Issue Date: January 18, 2017

"Regulations" Are Not A Bad Thing

By Jane Thibodeau Martin,

I hear politicians talking about "getting rid of regulations," like any regulation is a bad thing. I am proud to consider myself an environmentalist, so I am very concerned about what is going to happen to critical environmental protections. But certainly this goal of getting rid of regulations extends to other areas as well, and that also gives me pause.

I ran across some information recently about something that happened so long ago, nearly 60 years, that many of you may never have heard about it. It is a horrible tale, but it features an amazing and unlikely heroine, a woman named Frances Kelsey. She was an FDA inspector for the Food and Drug Administration in the United States, and it was because of her that untold thousands of American children were spared a terrible medical miscalculation.

This story of a dangerous drug has stayed with me all my life, when as a little girl I watched TV news stories and saw newspaper pictures about thousands of infants born in other countries like Canada and England with a condition called "Phocomelia," - a birth defect resulting in total absence of arms, in many cases with their hands attached directly to their shoulders. There is no controversy about what caused the highly unusual birth defect - it was a drug called Thalidomide. And the pictures of the "flipper babies," as they were called, are unforgettable.

Thalidomide is still used, under very carefully controlled conditions, for the treatment of leprosy and for patients with multiple myeloma. It is approved by the FDA in the U.S. for those two conditions, but because of the known impact on fetal development, stringent control of the drug and the patient treatment is practiced.

The drug was originally used as a "safe" sedative for sleeplessness in England, but then an obstetrician in Australia also observed the drug was effective in treating morning sickness. This "off label" use of the drug was what eventually led to the shocking discovery that it was causing life-altering birth defects to children born to the women who took it, because it created a large pool of women using the drug who were also pregnant and consequently delivered terribly deformed babies. The doctor quickly made the connection, and the culprit was identified.

But before this awful discovery was made, there was tremendous pressure put on Frances Kelsey to approve the drug for its original use in the United States. She refused, citing the inadequacy of the study of the safety of the drug. Because of her refusal, parents in the United States were spared the heartbreak that was suffered by those in Europe, Australia, and other places. This was a drug that German inventors and researchers said was "so safe, we can't feed enough of it to a rat to kill the animal." Frances Kelsey didn't think that was good enough. The fatal mistake the researchers made was not considering the impact of the drug on fetal development, and an estimated 10,000 to 20,000 children were born horribly deformed because their mothers used a medication that both they and their doctors assumed was safe for pregnant women.

FDA regulations ARE quite burdensome, and they are expensive. But thinking about limiting them would put U.S. citizens at risk of another frightening "mistake," that Frances Kelsey protected us from, out of abundance of caution. And this "close call," caused the United States to further strengthen FDA regulations in the early 60's, with strong support from the public who welcomed the action. Because if you watch old black and white newsreels of children born with no arms, you are willing to embrace regulations to prevent such things from happening.

Unfortunately sometimes it takes such a disaster to create the political will to support or create regulations. Also unfortunately, once the will is created, it is usually way too late to "undo" the damage that has been done by the lack of regulation. We are innovating in all arenas world-wide; regulations are sometimes going to be necessary in safely implementing new technologies of all sorts. Science continues to evolve and identify situations, like potentially harmful impacts of innovations on people, animals and our environment, that will require control.

Removing existing regulations is not a task to be approached with recklessly-operated chain saws. Good understanding of the "why" of the existing regulations should be achieved before changes are made. Banking laws, environmental controls, and other regulations exist for a reason. Let's make sure our elected officials truly understand potentially negative consequences of whatever regulation they are dismantling before firing up those chain saws on our supposed behalf.

The harm done to the "flipper babies" can't be undone. It's up to you and I to let our current politicians know what potential risks of regulation removal are not acceptable to us. It has never been more important for us to get involved, because unfortunately, some of those who seek profit will always be reluctant to accept or support regulations that could suppress their ability to make money.

There are potential heroes and heroines among us right now raising their voices about the potential grave consequences of removing regulations. Some of these voices are those of the Frances Kelsays of our own time " we must be sure these voices are not shouted down or ignored.

You can reach me for commentary, alternative viewpoints or ideas at this e-mail address: Janiethibmartin@gmail.com.


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