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    Archive for February, 2017

    Please President Trump, Repeal the FDA! – Update 1

    Posted by Ivo Cerckel on 7th February 2017

    Thalidomide was marketed since 1957 in West-Germany but never in France.

    Update 1 adds the reason why thalidomide was banned in France.

    Disclaimer: I am a thalidomide monster.

    FDA is the Food and Drug Administration.

    In her 05 February 2017 New York Times article “Trump’s F.D.A. Pick Could Undo Decades of Drug Safeguards”, Katie Thomas says that:
    “Congress toughened the drug approval process in the wake of the worldwide crisis over thalidomide, which caused severe birth defects in babies whose mothers had taken the drug in pregnancy. Since then, the F.D.A. has come to be viewed as the world’s leading watchdog for protecting the safety of food and drugs, a gold standard whose lead other countries often follow.”
    https://www.nytimes.com/2017/02/05/health/with-fda-vacancy-trump-sees-chance-to-speed-drugs-to-the-market.html?_r=0

    Dr Eileen Cronin tweets
    Trump is taking us back to catastrophe: Deregulating the FDA: Back to thalidomide?
    11:03 am – 7 Feb 2017 GMT+8
    https://twitter.com/CroninMermaid/status/828801363194769413

    The tweet refers to her article two years ago

    Deregulating the FDA: Back to thalidomide?
    By Eileen Cronin, Ph.D. and Lisa Plymate, M.D. – 12/02/15 01:00 PM EST
    http://thehill.com/blogs/congress-blog/healthcare/261742-deregulating-the-fda-back-to-thalidomide#comment-3141297763

    In the article Dr Cronin says:
    “The U.S. tragedy was reduced by the FDA analyst, Dr. Frances Oldham Kelsey. Alarmed by the lack of scientific research to support thalidomide’s safety and despite pressure from the drug companies, she delayed approval, demanding more evidence. How many infants were affected in the U.S.”

    As I said eighteen months ago:

    Inventor of Thalidomide Frances Oldham Kelsey Dies
    Posted by Ivo Cerckel on August 9th, 2015
    http://bphouse.com/honest_money/2015/08/09/inventor-of-thalidomide-frances-oldham-kelsey-dies/

    Frances Kelsey, doctor who kept thalidomide out of US, dies aged 101
    +
    Canadian doctor refused to bow to pressure from makers of drug when she worked for the US Food and Drug Administration in the early 1960s
    +
    Associated Press
    Sunday 9 August 2015 02.07 BST
    http://www.theguardian.com/world/2015/aug/09/frances-kelsey-doctor-who-kept-thalidomide-out-of-us-dies-aged-101

    1.
    Thalidomide was definitely known in the year 1938 and [its] defects were noted in Phoenix, AZ (USA) in a medical journal that year. It was known as a cure for Hanson’s Disease and made by [Richardson]-Merrill Co. in [Cincinnati], OH (USA). I don’t know what action was taken, but a young female doctor named Frances Oldham Kersey (or Kelsey) recognized its dangers.
    [by] Theodore, Princeton, WV/USA
    (reaction under From The Times April 4, 2008 Thalidomide: 50 years on victims unite to seek more compensation Nigel Hawkes, Health Editor
    http://www.timesonline.co.uk/tol/news/uk/health/article3671815.ece

    Kelsey was the lady who in 1960 only joined the USofA Food and Drugs Administration (FDA).
    Once there, she further delayed thalidomide’s approval (thalidomide was marketed since 1957)
    and was given a Presidential award by USofA president Kennedy for that delay.

    Wikipedia says
    that Kelsey is credited SINCE NINETEEN THIRTY-EIGHT with her interest in teratogens – that is, drugs that cause congenital malformations,
    that 1938 was the date of the creation of the FDA,
    and that Kelsey managed to be appointed there in 1960
    http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey

    Frances Oldham Kelsey invented thalidomide and was given a Presidential award for this invention by USofA president John F. Kennedy.

    2.
    Thalidomide was marketed since 1957.

    Kelsey was only appointed in the FDA in 1960.

    How can she get (all) the credit for having ‘saved’ the US of A from it?

    3.
    Legal tabloids tell us that thalidomide is an example of the development-risk defence which allows producers to escape liability if they prove that the state of scientific and technical knowledge at the time when they put the product into circulation was not such as to enable the existence of a defect to be discovered, as defined at present “a contrario” (“argument based on the contrary” – denotes any proposition that is argued to be correct because it is not disproven by a certain case, says Wikipedia) in article 15(1)(b) of the 1985 EEC Product Liability Directive, formally Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.

    Dr. Herman Cousy, professor emeritus from the law department of the K.U. Leuven,
    has demonstrated in 1996 that the thalidomide scandal cannot be considered to be an example of the development-risk defence
    by saying on p. 163, in note 28,

    of his paper “The Precautionary Principle: A Status Questionis” published in the “Geneva Papers on Risk and Insurance – Issues and Practice”, also available on the website of the “Geneva Association”, l’”Association Internationale pour l’Etude de l’Economie de l’Assurance”, the leading international think tank of the insurance industry, that :

    “One often cites the Thalidomide (Contergan) case as an example of a development risk situation, although it appears that when thalidomide was brought onto the German market, the product had been banned in France. Can it be readily upheld, under such circumstances, that the conditions for a development risk situation were fulfilled?”
    https://www.genevaassociation.org/media/231494/ga1996_gp21%2879%29-cousy.pdf

    This means that the primary cause of the thalidomide scandal is the fact that after the French Leviathan had banned thalidomide, other Leviathans, whose main reason for existence would be to “protect” their citizens, did not prevent the product being brought onto “their” markets nor did they immediately order the withdrawal of thalidomide from “their” markets, once the product appeared there after the French ban.

    The primary cause is opposed to the (Aristotelian) efficient of the thalidomide scandal, the tablet.

    For Aristotle, 25 centuries ago, the efficient cause is the being in act who brings about the change. And Aristotle went on to give the example of the sculptor who makes the … statue. Was this example devised 25 centuries ago with thalidomide monsters in mind?

    4.
    Kelsey was Canadian, wasn’t she?

    Why are there victims of thalidomide in Canada?

    END of my 2015 post

    Thalidomide been banned in France because
    as The (London, England) Sunday Times said on 08 February 2009
    ” Grünenthal, the maker of the drug, apparently purchased the trade name of the drug – Contergan – and therefore probably the substance itself, from a French firm, Rhône-Poulenc, which was under Nazi control during the war years,”

    From The Sunday Times
    February 8, 2009
    Thalidomide ‘was created by the Nazis’
    http://www.timesonline.co.uk/tol/life_and_style/health/article5683577.ece
    Link does no more work
    copied here
    http://www.fourwinds10.net/siterun_data/health/harmful_products/news.php?q=1234215547

    Please President Trump, Repeal the FDA!

    Ivo Cerckel
    ivocerckel@siquijor.ws

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