In today's Science Times section of the NY Times is an article about Dr. Frances (Oldham) Kelsey, 88. She was responsible for preventing the William S. Merrell Company from marketing Kevadon, a sedative used to reduce morning sickness in pregnant women. The generic name of this drug is thalidomide. If you are my age (59) you shudder when you think of the phrase "thalidomide babies." Many children born to women who took thalidomide were born limbless or with very truncated appendages.
The drug was used in Europe where thousands of children suffered this fate. In her first assignment with the FDA she prevented the company from getting approval. It is very likely, according to the NY Times article, she might not have gotten the job to begin with if her first name did not sound like a man's.
When a woman took a job in those days, she was made to feel as if she was depriving a man of the ability to support his wife and child," Dr. Kelsey said in an interview at her home. "But my professor said: ‘Don’t be stupid. Accept the job, sign your name and put "Miss" in brackets afterward.’
Before 1960 the approval process for introducing new drugs into the market did not require hard scientific testing data for effectiveness and safety. Another quote from the article.
Drugs could be sold 60 days after their makers filed information with the agency as long as it did not object; companies routinely sent new remedies to doctors and asked them to try the medicine in patients. Such testing was uncontrolled and entirely anecdotal.
Her contribution, along with a group of new hires at the FDA in 1960 who began to demand scientific data for approval, have changed the way the world now tests new medicines before they are allowed to be used by the market. For the last few decades industry has led the effort to emphasize speed over safety in the approval process. There are many examples in the recent past of medications that have been linked to severe side effects and death. Avandia, the diabetes medication, and Vioxx, the pain killer, are two examples. The bureaucrats and their bureaucracies can be a real problem too. The recent salmonella outbreak in eggs from large egg farms is another where lax communication and split responsibility between the USDA and the FDA led to this problem. The regulation process is difficult but that does not mean we should minimize it.
Industry most often tries to shortcut the approval process to maximize their profits. The public suffers. Federal regulation is a very good thing! Is it cumbersome? Yes. Is it effective most of the time? Yes. One of my best friends (even though he votes Republican) has a painting business. He has complained about the new requirements regarding lead paint. They are now required to get a training to continue the painting and are required to use a comprehensive containment process for older, pre-1978, buildings. "Liberal government bureaucrats" are at fault he says. But if you look into the research that lead to the regulation there is a potential for 250,000 children to be affected by the lead paint that may get into the environment if these new regulations were not enacted.
I want big brother in these caspacities watching out for me. And most people benefit. When the naysayers are effected they complain that the bureaucrats are not doing their job. But if they do their job they complain.
I say support those federal regulations. They have kept our environment a great place to live. Whether it is our air, water, food or drugs I want a scientist and a bureaucrat regulating it so my family and I can be safe. I do not trust business to reduce their profits so I will be safe!