Friday, January 15, 2010

Puzzled Again

In the House of Commons this week a Health Minister apologized for the thalidomide tragedy, which occurred 50 years ago. Such apologies are politically fashionable, but this one is especially nonsensical.

Neither the minister nor the government was responsible for the disaster, then or now. What meaning is there when apology has no link to responsibility?

Thalidomide, trade name Distaval, had satisfied the regulations then current for prescription in Britain. It was marketed and prescribed as a sedative drug with a wide margin of safety. I remember Dista's advertisement: a child on a stool at the medicine cupboard in the bathroom, looking at a handful of tablets from a bottle; the caption read "This child's life may depend on the safety of Distaval".
It proved to be beneficial in pregnancy sickness, but it had not been tested for safety in pregnancy. Foetal damage by a new drug was not recognized to be a danger at that time, and the licensing regulations were easy on this issue.
Now, of course, exhaustive testing for safety to the foetus is mandated for all new drugs: the lesson was learned.
Those made confident by 20/20 hindsight may criticize the regulations in force 50 years ago, but the justice of so doing is doubtful.

The drug was withdrawn immediately with recognition of the association between the limb deformity called phocomelia and Distaval.
More recently Distaval has been used to control the "upgrading" reactions which may occur during treatment of leprosy, with inevitable misuse of this psychotropic drug. Consequently new cases of phocomelia are reported from Brazil and other countries.

All drugs have side-effects. Extensive testing of a new drug identifies only the more common problems. Drugs may be in regular use for years before a serious hazard is identified: examples include phenformin and lactic acidosis, practalol and sclerosing peritonitis, rofecoxib [Vioxx] and thrombotic vascular crisis.
It is hard to attribute guilt and liability for a problem which could not reasonably be foreseen.

The Distaval Disaster is exceptional only because the unforeseen side-effect proved to be exceptionally tragic.

[Drug companies strongly encourage doctors to prescribe drugs by trade name. But somehow approved names become appropriate when there is a problem. So 'Thalidomide Tragedy' is now in common use; Distaval Disaster is not - despite its alliteration.]

What the government should admit is its mistake in permitting general practitioners to work office hours only, ignoring warnings of problems and dangers, with consequences now in the headlines.

Apologize when you are not guilty, but don't apologize when you are.
I just can't get my head round that.


No comments: