When Government Regulation Saved American Babies
The Republican Convention hosted speaker after speaker who promised to limit government regulation and give business free rein to do what they do best– pursue profit and, if we’re lucky, create jobs. The speakers had nothing good to say about agencies such as the Environmental Protection Agency, which they would abolish, and expressed complete faith in the free market to supply all the checks and balances Americans need. In the same week, we saw the fifty year anniversary of one of the most terrible betrayals of a trusting public ever carried out. That our own country was less affected is thanks to a government agency, the Food and Drug Administration, and to one skilled and loyal public servant who resisted industry pressure.
German pharmaceutical company Gruenenthal Group has issued an apology, fifty years on, to the individuals and families whose lives were devastated by the effects of Thalidomide. If you are old enough to remember the news photos of limbless babies and children you will hope their suffering has not been in vain.
It could have been me, or one of my brothers or sisters. One pill from a sample pack in early pregnancy was enough to cause major birth defects. An American drug company was lobbying hard to import Thalidomide and market it to pregnant women here as a remedy for morning sickness. One woman, a government regulator in a mostly male workplace, stood in the way.
From the New York Times, September 14, 2010—
CHEVY CHASE, Md. — She is unlikely to be mentioned at any 50th-birthday parties this year, but she is the reason many of those celebrations will take place.
Dr. Frances Oldham Kelsey is 96 now, nearly deaf and barely mobile, as modest as her faded house in this Washington suburb. And though her story is nearly forgotten, she was once America’s most admired civil servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug thalidomide and in serving as midwife to modern pharmaceutical regulation.
On Wednesday, Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, will honor Dr. Kelsey with the first Kelsey award. It will be given to a F.D.A. staff member annually. The award will come 50 years after Dr. Kelsey, then a new medical officer at the agency, first sat down to consider an application from the William S. Merrell Company of Cincinnati to sell a sedative named Kevadon, which was widely prescribed in Europe for morning sickness in pregnancy.
As it turned out, the drug (better known by its generic name, thalidomide) would cause thousands of children in Europe to be born limbless or with flipperlike arms and legs. With her probing analysis of Merrell’s application and her insistence on scientific rigor, Dr. Kelsey ensured that the effects in the United States were far more limited.
The thalidomide disaster led Congress to pass legislation giving the F.D.A. authority to demand that drug makers prove their products safe and effective. Moreover, Dr. Kelsey helped write the rules that now govern nearly every clinical trial in the industrialized world, and was the first official to oversee them.
Today Thalidomide is marketed for some cancers and for some complications of AIDS, but I’m not happy to see it back, no matter how many safeguards they put in place. The acne drug, Accutane, can causes birth defects, and a program to prevent use by women who might become pregnant has not been as successful as it might be if people were rational and doctors never cut corners.
Regulations are a nuisance and a burden until some awful failure reminds us why we have them. Can we learn from the past, or will we put quick profit ahead of public health and safety?
Thank you Doctor Kelsey, for all the lives you saved, for all the sorrow you prevented. The free market may be fine for deciding what color shirt to buy, but when you have to trust that a drug is safe, a car is road-worthy, food isn’t contaminated– then you need some gummint interference.
Unnecessary Risk
This is a good example of why we need an FDA, and why nothing is risk-free…
New Jersey-based Pharmaceutical Innovations Inc. manufactures Other-Sonic Generic Ultrasound Transmission Gel. The gel is used by medical professionals in ultrasounds, a procedure involving high-frequency sound waves to look at patients’ organs. Samples of the gel taken by the FDA in February contained two strains of bacteria.
“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” the FDA’s Dara Corrigan said in a statement. Additionally, the FDA issued a safety alert to health care providers about the bacteria risk and possibility of dangerous infections from the gel.
We have politicians playing doctor, demanding that women get unnecessary vaginal ultrasounds before an early abortion. This is based on two faulty assumptions– that women don’t know what they are doing, and that any medical procedure is risk-free. Not least is taking medical resources from where an ultrasound is needed and beneficial, and applying those scarce resources with the intent of causing emotional harm. It’s unexpected that the contaminated gel has caused patients physical harm, but medicine is all about the unexpected.
We have politicians calling for deregulation. A government agency like the Food and Drug Administration is our line of defense against negligent manufacturers who sell a dangerous product to the public.
So, this morning, two thoughts that came to my mind reading about the 16 people who got sick from contaminated ultrasound gel.
Saved by ‘Gummint Interference’
From the New York Times, September 14—
CHEVY CHASE, Md. — She is unlikely to be mentioned at any 50th-birthday parties this year, but she is the reason many of those celebrations will take place.
Dr. Frances Oldham Kelsey is 96 now, nearly deaf and barely mobile, as modest as her faded house in this Washington suburb. And though her story is nearly forgotten, she was once America’s most admired civil servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug thalidomide and in serving as midwife to modern pharmaceutical regulation.
On Wednesday, Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, will honor Dr. Kelsey with the first Kelsey award. It will be given to a F.D.A. staff member annually. The award will come 50 years after Dr. Kelsey, then a new medical officer at the agency, first sat down to consider an application from the William S. Merrell Company of Cincinnati to sell a sedative named Kevadon, which was widely prescribed in Europe for morning sickness in pregnancy.
As it turned out, the drug (better known by its generic name, thalidomide) would cause thousands of children in Europe to be born limbless or with flipperlike arms and legs. With her probing analysis of Merrell’s application and her insistence on scientific rigor, Dr. Kelsey ensured that the effects in the United States were far more limited.
The thalidomide disaster led Congress to pass legislation giving the F.D.A. authority to demand that drug makers prove their products safe and effective. Moreover, Dr. Kelsey helped write the rules that now govern nearly every clinical trial in the industrialized world, and was the first official to oversee them.
Doctor Kelsey resisted pressure from the pharmaceutical corporations and lobbyists to be a good girl and just go along. She was a female in a male organization, and the one doctor who stood in the way of a drug that left such a path of destruction in Europe being pushed on pregnant women in the US.
Today thalidomide is marketed for some cancers and for some complications of AIDS, but I’m not happy to see it back, no matter how many safeguards they put in place. The acne drug, Accutane, can causes birth defects, and a program to prevent use by women who might become pregnant has not been as successful as it might be if people were rational and doctors never cut corners.
Thank you Doctor Kelsey, for all the lives you saved, for all the sorrow you prevented. The free market may be fine for deciding what color shirt to buy, but when you have to trust that a drug is safe, a car is road-worthy, food isn’t contaminated– then you need some gummint interference.
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