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Thalidomide

As a counterpoint to the post about the mouse, it is worth remembering that sometimes suspicions of harm can be true. Here are thirteen facts about thalidomide, some of which you might not have known.

  1. Chemie Grünenthal, who developed thalidomide (Contergan in Germany, Distaval in the UK), had two drugs pulled from the market prior to thalidomide due to adverse effects. Neither had been adequately tested.
  2. The Director of Research, Dr Heinrich Mückter, at Chemie Grünenthal was an ex-Nazi Medical Officer who joined the company after serving in the occupation forces in Krakow, Poland. Little is known about his role during this time.
  3. Before testing in humans Chemie Grünenthal were unable to find pharmacological activity in animals, and they distributed free samples to doctors and employees without monitoring or follow-up to look for benefits. One commentator said “thalidomide was introduced by the method of Russian roulette. Practically nothing was known about it at the time of its marketing”.
  4. “If all the details of this are true, then it is a most remarkable drug. In short, it is impossible to give a toxic dose.” Dr Walter Kennedy, Chief Medical Advisor to Distillers Ltd after a trip to Chemie Grünenthal’s HQ before buying the rights to market thalidomide in the UK.
  5. Thalidomide was sold freely over-the-counter, without prescription, in Germany, where the liquid form (nicknamed “babysitter”) was used to sedate children at the cinema.
  6. The first victim of thalidomide was the daughter of an employee of Chemie Grünenthal on Christmas day 1956, who had given his wife samples provided by the company. Born without ears ten months before the marketing of thalidomide the lack of monitoring by Chemie Grünenthal meant that this event was not linked to thalidomide until its withdrawal.
  7. Chemie Grünenthal deliberately lied about reports of polyneuritis they had received and put patients and doctors who complained about polyneuritis under surveillance, finding in one case that a doctor’s father was “an ex-communist and nowadays a member of the social democrats”.
  8. Dr William McBride, the first person to make the link between thalidomide and birth defects, first prescribed the drug in pregnant women following a medical representative’s advice.
  9. Chemie Grünenthal’s motto was “we must succeed at any cost”.
  10. When confronted with evidence of polyneuritis and a suggestion that thalidomide should become prescription only in Germany Dr Heinrich Mückter said to his fellow company executives: “The fight for Contergan must go on to the bitter end”
  11. Thalidomide

  12. Distillers Ltd sent out in 1961 promotional leaflets stating “Distival can be given with complete safety to pregnant women and nursing mother’s, without adverse effect on mother and child.. “ Neither Distillers or Chemie Grünenthal had conducted any studies in pregnant or nursing mothers.
  13. Richardson Merrell, the US marketers of thalidomide, had ten million doses ready to go to market if the FDA had licensed thalidomide.
  14. Even without a licence, Richardson Merrell distributed two and a half million doses to 20,000 patients monitoried by 1297 physicians as part of an “investigational study”. Doctor’s were told it was unnecessary to report any adverse effects to the company. Patient records were poor, and company records of which physicians were supplied were incomplete. Eleven thalidomide babies were born in the US. Poor records may have hidden other harms.

For more on thalidomide, read Dark Remedy.

One Comment

  1. I wonder whether we are really doing much better right now.

    It reads pretty much like the current state of the industry (albeit now clouded in mounds of reassurance from regulators who have in many cases neither seen nor retained actual data.

    Disasters waiting to happen (they are happening already).

    Aubrey

    Posted on 24-May-07 at 12:39 am | Permalink