Letter: Letters : Tragic time-lag

From B. Meredith Burke

Palo Alto, California

I was delighted to read of the growing recognition of the serious
psychotropic and physical dangers of the anti-malarial Lariam (mefloquine)
(“Malaria pill stands accused”, 27 April, p 14). My letter warning of these
appeared in The Lancet (p 1605, June 19, 1993). It promptly
precipitated a retort by Feiko O ter Kuile et al implying that I had naively
generalised from one case, and rejecting my advice to use chloroquine with or
without proguanil, the treatment now being touted.

My letter of 6 July, 1993, to David Kessler of the US Federal Drugs
Administration evoked a mere delaying response. In the Federal Register of July
22, 1993, the FDA itself reported the results of a Government Accounting Office
study on the demographics of drug trials for new drug applications. This showed
that 89 per cent of those in Lariam drug trials were male, a sex bias so extreme
that the report singled it out, explaining that “the primary studies of
mefloquine . . . were conducted in Thai military personnel”.

Alas, Katherine Forrest, a friend who had merely followed CDC recommendations
in initially prescribing Lariam for me (and who had filed an adverse drug
reaction report), found this announcement a full year after it was published.
Although I promptly wrote to The Lancet, it considered its pages could
deal with only more recent reports.

I provide this history so that readers and policy makers alike may realise
the time-lag involved and the tenacity required to challenge major
pharmaceuticals companies and government agencies about a drug once it has been
approved.