U.S. Food and Drug Administration
FDA Consumer magazine
May-June 2001
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How does a country show a debt of gratitude? At first glance, a presidential medal and induction into the Women's Hall of Fame seems to be enough. But in reality that falls far short for a person who stood alone against a powerful drug company that was willing to do just about anything to have thalidomide approved for American consumers with the goal of selling the drug over-the-counter!
The problem with properly thanking Dr. Kelsey ("Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History," March-April 2001 FDA Consumer) is we don't know exactly how much she did for us. How many pregnant women in the United States would have taken thalidomide if it had been available? Thousands? Hundreds of thousands? Would the number of American thalidomide babies born been catastrophic when compared to the rest of the world? Probably. But who knows ... and that's why it is difficult to comprehend our debt to Dr. Kelsey.
This is not a new story to some of us who have been touched by thalidomide. In 1960 my aunt and uncle were traveling back to the United States on a furlough from their mission work in North Africa. The ship's doctor gave Aunt Joanne thalidomide to help her sleep during a bad bout of seasickness. Seven months later my cousin Terry was born with badly deformed or missing arms and legs. My aunt always used to say the Lord took her son's arms and legs, but he gave him a brilliant mind. Today, Terry is laser scientist for a company in London with a wife and two children. A success story on any level!
Thanks to FDA Consumer, at least some are reminded of a 40-year-old story and the lasting impact one woman had when standing alone for what was right.
Mark Eaton
I am one of the many people whose lives have been adversely and tragically affected by the withdrawal of Lotronex from the market. I am 73 and have been subject all my life to diarrhea so severe and unpredictable that I often could not fulfill business responsibilities, was unable to sit through a concert or theatrical performance, and nervously staked out the toilet facilities in every new place I went. Travel was difficult, and worst of all was the threat of a bout of humiliating and uncontrollable fecal incontinence.
After years of trying various drugs and regimens, I started to take Lotronex and was able, for the first time, to live normally. I had NO adverse side effects. I cannot convey the terrible impact the lack of this drug has had on my life. This is not a matter of the abstract definition of the term "quality of life." For many of us, the use of Lotronex actually gave us a life. Surely the FDA and the drug company can work out a plan of supervised prescription and administration that would get the drug back to those thousands of people to whom it was so important.
Charlotte Mayerson
Editor's note: Watch for more on irritable bowel syndrome and potential treatments in an upcoming issue of FDA Consumer.
Regarding the article "A New Kind of Fish Story: The Coming of Biotech Animals" from the January-February 2001 FDA Consumer: The FDA's responsibility is not to act as technological proponents, but rather, to evaluate the impact and safety of foods and drugs.
The FDA seems to wholeheartedly support the introduction of untested and risky technologies such as transgenic fish. If the administration's goal is to undermine the purpose of regulatory agencies by directing their administrators to violate the public trust by providing false or one-sided information, then the administration's goal must also be to undermine American democracy in general for its own selfish goals and desires.
The introduction of transgenic fish clearly threatens to destroy wild species, replacing them with inferior transgenic stock without migratory instincts. Without sufficient regulation, their introduction could have catastrophic results on the aquatic food chain. It is not in the best interests of America for the FDA to turn a blind eye to this or any other technology.
Neil Sorensen
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