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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12 responses

  1. I disagree-there are already numerous drug regimens for cancer that make Thalidomide look like Tylenol.
    It’s like medical marijuana-evryone jumps up and down and gets red in the face over it,and yet your doctor can still give you heavy duty narcotics like fentanyl,hydromorphone, methadone,numorphan,etc.etc.-try to fugure that out.

  2. Having taken care of people who opted not to get treatment for their cancer, I’ve seen that it’s a terrible disease that causes suffering, disfigurement and death. That’s why people choose amputation and dangerous drugs with the hope of surviving, and many do.
    Thalidomide was marketed as a cure for morning sickness– something you could treat with ginger tea. it was prescribed for pregnant women– the one group who should never take it. I’ll never forget the pictures of limbless babies. This could have been someone in my family– born in the fifties and sixties.
    Sometimes you need government regulation.

    1. Gee,no argument from me on government regulation.Giving thalidomide to pregnant women was a crime-they obviously didn’t try very hard to determine dangers.I remember it too.
      You wouldn’t give cisplatin or oncovin or procarbazine to a pregnant woman either,but those drugs routinely have saved lives for decades.So the drug itself is useful,just for something they didn’t envision.

  3. Sometimes?

    How about the bout with botulism that we had this summer. Eat fressh veggies for your health, and get botulism.

    All because the GOP and their Tea-Party running dogs have done all they can to gut all the safeguards we’ve put in place.

    Yes, there are all sorts of nasty drugs out there. Which is why they need heavy regulation. And nn’s point is well taken: thalidomide was given for something that is temporary and not at all dangerous.

    But Big Pharma assured us it was safe. And a good idea.

    1. What botulism occured from fresh(not canned) vegetables?Are you thinking of e.coli?
      Botulism can only occur in an anaerobic environment.An exception is honey in children under one year old.

      1. OK-there have been cases reported of botulism from certain fresh vegetables improperly stored,but they are exceedingly rare.Botulism spores exist everywhere-they normally only develope into the toxin producing stage as a result of improper canning of low acid foods,including meat products.It can also occur in oily products that contain,in addition to the oil itself,vegetable products.Lack of refrigeration is the usual culprit there.

  4. The point is, we don’t have home laboratories to test our food and drugs for every possible contaminant.
    I have a lot of confidence in cooking as a way to kill germs and I’ve never had a problem. But nobody eats 100% local. A nice little farm stand I shopped at was getting their nectarines from California. There are potentially harmful substances that are undetectable, such as insecticides and herbicides, not to mention GM.
    And how am I supposed to evaluate whether the company that makes my prescription drug is up to standards?
    We need transparency, strong regulation and good science to protect the public.

    1. Cooking at boiling and above for a sufficient amount of time kills e.coli,salmonella,and botulism.
      Listeria however,typically occurs in foods that don’t get heated up.It usually doesn’t affect healthy adults,but can be very deadly for immunocompromised people,older folks,and children.

  5. Especially when we allow all kinds of food and drug products in via NAFTA and from China with virtually no QC being done.
    We’re not arguing here.

  6. The supermarket shrimp from the other side of the world makes me nervous.

  7. Wow-you just hit on something I was going to bring up,but forgot.Thanks.
    International food processing specialization.
    The ‘supermarket shrimp”from the other side of the world are most likely from Thailand-that country has specialized in processing shrimp for international packaged sale.
    Morocco has specialized in sardines,particularly the skinless and boneles variety.
    Indonesia has specialized in larger sized cans of crabmeat.Iceland in Arctic char.Ireland in smoked eels.
    Portugal also does sardines as a national industry.
    I see it this way-if I’m going to have a heart bypass,I want to go where they do them every day,not once in awhile.
    Specialization usually creates a more professional and competent environment.
    I’d be a lot more confident buying a product that originates from a place that’s made a major industrial concentration around it.They probably have the “bugs”ut of the process,
    I don’t extend that to produce from Central America.Dirty water and poor hygiene make it risky.
    Chile is a different story.

  8. Dominique Millette | Reply

    Thank you for this fascinating post. It sounds like someone should make a movie out of her!

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