Friday, August 14, 2015

FDA heroes reminds us of the need for government meddling


     One evil is so clear to Republicans that it didn't need to be discussed at all during their presidential debate in Cleveland last week: government regulation.
     The 10 candidates jostled to condemn government meddling.
     "We cut regulation by one-third of what my predecessor put in place," bragged New Jersey Gov. Chris Christie.
     "You get in and change every aspect of regulations that are job killers," said Jeb Bush.
     "We need to have a regulatory budget in America that limits the amount of regulations on our economy," said Marco Rubio.
    By an odd coincidence, one of the better known of those demonized regulators, Dr. Frances Kelsey, died the next day, at age 101.
Frances Kelsey at the FDA

     In 1960, Kelsey, University of Chicago Medical School class of 1950, was a new hire at the Food and Drug Administration in Washington, D.C. One day in September a trio of three ring binders, each the size of a phone book, landed on her desk.
     It was an application from William S. Merrell, an Ohio drug company, that wanted to sell a drug it called Kevadon in the United States. Kevadon was a sedative, effective against nausea in pregnant women. Approval was expected to be routine: the drug was already being sold under various names all over the world.
     But as she read the Merrell application, Kelsey had qualms. "There was something a little different about this one," she later remembered thinking.
     According to law, the FDA had just 60 days to register an objection. Otherwise, Merrell could go ahead and sell the drug in the United States—it was already giving samples to U.S. doctors; eventually 1200 doctors would get them, and starting handing out free pills without telling patients they were unapproved, a field test by the unaware, all completely legal.
     But before the 6o day limit ran out, Kelsey wrote to Merrell saying despite their findings' bulk, they were "incomplete." She had questions about methodology.
     Merrell howled. Executives came to Washington in droves to complain about the "stubborn bureaucrat." They sent letters to her superiors, made phone calls, placed editorials in medical publications denouncing "dilatory tactics which certainly cause a loss to the industry of millions of dollars ... and even loss of life." Kelsey was being "unreasonable and irresponsible." Language any Republican presidential candidate knows by heart.
     While Kelsey was engaged in what Scott Walker would call "out-of-control regulation," a letter was published in the February, 1961 issue of the British Medical Journal noting reports of "a possible toxic hazard" with the drug. After the letter, Merrell wondered if they could perhaps sell their drug with a warning label. As 1961 dragged on, the company expressed concerns it would "miss the Christmas market."
     But by Christmas the struggle was over. In West Germany, where the sedative had gone on sale in 1957, a report linked an epidemic of malformed children to the drug, which was sold under 50 brand names, but generically known as thalidomide. Tens of thousands of children around the world were born with severely malformed limbs resembling flippers, or no limbs at all.
Dr. Kelsey received the President's Award for
Distinguished Federal Service from JFK.
     But not in the United States, except for a few whose mothers got those free samples. President Kennedy gave Kelsey a medal. Laws were tightened. She worked for the FDA for nearly 45 years. Long enough for the thalidomide story to fade from the public mind.
     I don't want to let one dramatic story goad me into extremism. The flip side of the "Frances Kesley ethic" is that valuable drugs are sometimes needlessly delayed. There can be too much government interference in business, as the advent of Uber demonstrates. Certain trades—hair braiding—are licensed that shouldn't be licensed at all.
     That's called "nuance." It might not play well in a sound bite, but in real life there is a balance, or should be, between caution and expediency. We need the government to rein in business because otherwise it'll sell thalidomide and put 12-year-olds to work in thread factories. We know they will because they've done it before. Government regulators make mistakes, but they also do enormous good, and don't deserve the sneering, blanket contempt Republican candidates heap upon it. Nor does the public.
     Among those watching the GOP presidential debate, thousands were 54 year old businessmen and Tea Party grandmothers,, jaws clenched in righteous anger at the foolishness of government meddling, owe their arms and legs, their hands and feet, to one stubborn FDA bureaucrat, Frances Kelsey, who understood the need for government regulation. These lucky men have no idea of the truth underlying their entire lives. There's a lot of that going around.

27 comments:

  1. Took a couple minutes to get the 54-year-old reference. You're almost in that demographic, right? Fortunately, your mother wasn't one of those getting those much coveted "free samples."

    john

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    1. I think that's one reason this story is so personal. I'm 55. Thalidomide was being sold in Europe and my father, a nuclear physicist, went there all the time. I can still see where I was, as a boy, reading one of those "Heroes of the FDA" young teen books, about it. It was absolutely horrifying.

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    2. It wouldn't surprise me if some conservatives back then told her she belonged in the kitchen.

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  2. Thank you for a wonderful article about Dr. Kelsey. I learned about her work with the FDA during some on the job training about 15 years ago and I continue to tell people about her work all the time. What an impressive person!

    And well done to remind people that regulation has its place in the world. Without it, we would all be a lot worse off.

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  3. Very informative. Saw another article on her too recently. It's best not to trust the polluting and greedy Repubs, big Pharma, Big Oil, Tobacco, NRA or any large corporation or utility companies. Repubs would also poison our air and water if it saved the company some money. Unfort. the Chinese govt or Indian one doesn't care about that. Now some may come on here and say not to generalize about Repubs, but for the most part, this is the case.

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    1. and add some organized religions to that too- as leaders can't be trusted

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  4. Neil,

    Could you share your source for the "Miss the Christmas market" quote? I'm just curious. Seasonality isn't usually a factor in sales on most pharmaceuticals (flu meds and stuff like that aside); so it seemed odd to me.

    This is a great example of how simple arguments like we need to cut regulations/taxes completely ignore the complexity of the real world.

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  5. A quick Google search turns up this Life magazine articles from August 10, 1962:

    https://books.google.com/books?id=Hk4EAAAAMBAJ&pg=PA28&lpg=PA28&dq=merrell+miss+the+Christmas+market&source=bl&ots=IUJoypb2Mx&sig=75065WDLJa7yCFxPe_lJPxUoaKM&hl=en&sa=X&ved=0CCIQ6AEwAWoVChMI5vPbq-OoxwIVwz0-Ch0H-wFY#v=onepage&q=merrell%20miss%20the%20Christmas%20market&f=false

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    1. I agree, Chris, that that's a weird product to market for Christmas.

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    2. That is indeed where I took the Christmas quote, and several others, from.

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    3. Thanks for the quick response. I still somewhat doubt the veracity/seriousness of the remark if it was made, but I could see an overzealous marketer saying it.

      It reminded me of the underrated Kids in the Hall comedy "Brain Candy" where the pharma company laments not having a "back to school" offering.

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    4. Nice googling, Coey! That DOES seem kinda odd. Everybody knows that guns are the product best suited to the "Christmas market".

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    5. Especially the official Red Ryder, carbine action, two-hundred shot range model air rifle!

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  6. Excellent article. As I tweeted out to you earlier, I think this deserves to be in the paper as more people probably read you there. I had never hear of Kelsey before. I was only 13 or 14 when the the thalidomide stories came out. I remember watching news stories and even reading about it.

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    1. It is in the Friday Sun-Times, Sanford

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  7. Thanks for this. Every right-winger who waves around some dubious anecdote about the gummint shutting down a kid's lemonade stand should get this batted back down his throat.

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  8. well said, Scribe

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  9. I didn't see the debate, so I may be missing the points that the candidates were trying to make. First of all, I am a fiscal conservative. It sounds like Bush and Rubio were making the case that there are regulations which stifle economic activity and should be reviewed. An example might be the recent EPA requirements to reduce carbon emissions from electric generating stations. This is an admirable goal and should be pursued, but a down side is that are approximately 150,000 people involved in coal mining and secondary industries today in the U.S. that stand to lose their jobs. I understand that there are some provisions in the Act that discusses retraining of the displaced personnel, but that's just BS if there aren't any jobs that are available for these folks to actually do. So wouldn't it be a much better Clean Air regulation if it specifically acknowledged the financial impacts and proposed specific steps to address them? I worked for a family owned business for a lifetime and we went through many years of automating and streamlining our manufacturing processes to stay competitive. Each one of these actions reduced the number of people involved in manufacturing, but we never implemented any of the process improvements without a concrete plan for what to do with the displaced workers. Our business was growing so a lot of folks went into other part of the company, in addition to skilled trades training programs, college education programs, and pay protection plans for people who weren't able to get into higher skilled positions. Oh, and the owner was about as conservative and Republican as they come.

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    1. I do have a soft spot for coal miners, all that they suffered historically and due to respect for the UMW. I'd hate to see them jobless.

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    2. Small businesses aren't the problem and yes they often side with moderate Republicans. It's big corp and Wall St. that is often enabled by the conservs. I empathize with small businesses.

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    3. Small businesses don't get the corporate welfare or the lobbying power that Big Corp. get. I don't think Dem leaders are necessarily anti- small business.

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    4. Sounds admirable but in the real world it's apt to be one of those beautiful theories murdered by a gang of brutal facts. A privately owned firm's owners may wish to do everything they can to help displaced workers, but in a competitive industry there is only so much they can spend on such efforts without raising costs and losing business. Or eating costs and going bankrupt. Managers of a publicly owned business must also contend with their fiduciary responsibility to provide stockholders a good return on investment, as well as a certain knowledge that their own success is directly related to the bottom line.

      That's why much of the burden of taking care of displaced workers in a free enterprise system falls on government unemployment compensation and retraining programs. And Republicans generally view such programs as "giveaways.

      Tom Evans

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    5. Good points.Companies can only do so much. I guess what I'm trying to say, maybe not so well, is that government agencies should do a better job of identifying all the impacts of their actions and regulations and have plans (or at least an acknowledgement ) to address them long term.

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  10. Speaking of Repubs, why is columnist Sneed always blowing smoke up Trump's rear?

    Then again, she used to feel sorry for George Ryan forgetting about his indirect victims.

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  11. Maybe the best case I've ever seen for government regulation is the removal of lead additives in gasoline. This took fifty years. Likely positive effects of its removal range from falling rates of violent crime to rising IQs. Yet there is no question that "the Market" would never have reached that point on its own without all that meddling regulatory prodding.

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    1. I agree removal of lead was huge. But there are other examples. When I first went to school on Chicago's south side in the 1950s I swept coal dust from my window sill every morning. And the beaches were becoming badly polluted. Not perfect now but much better due to EPA. A polluting business is unlikely to make costly changes on its own because it will put it at a competitive advantage. A government mandate levels the playing field.

      Tom Evans

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