A few weeks ago, the British government, in one of the most dramatic moves in the 30-year history of the Pill, issued a warning against seven brands containing one of two of the so-called “low dose” progestogens, desogestrel and gestodene, carry twic
The government claimed the warning resulted from data in three unpublished studies, comparing different generations of oral contraceptives.
As a result of the studies, Germany has lately followed suit, and the US Food and Drug Administration is reviewing the data for desogestrel. It has never allowed gestodene on the US market.
The press pounced on the supposedly inept and precipitous manner in which the government made its announcement, rather than the implications of what it was saying, and the actual reason for it.
In other words, instead of the Pill being on trial, the British government is.
According to the Sunday Times, the British government was prompted to review the data after a World Health Organization study of 17 countries demonstrated that these Pills had a higher incidence of blood clots. They then asked to see the preliminary results of a study being done by Canadian epidemiologist Professor Walter Spitzer for Schering, manufacturer of gestodene, which revealed a one and a half to two times increased risk, compared to other pills. An emergency trawl of the GP database, which contains information of certain doctors about all their patients, confirmed these results, which is when the Committee on Safety of Medicines promptly decided to issue its warning.
There was also, incidentally, the pressure of the current legal action by nearly 200 women or families of women whose thrombosis or pulmonary embolisms and strokes allegedly have been caused by these pills, in some cases within weeks of first taking the drug.
The word on the street from epidemiologists and sources close to the drug companies is that the government’s hasty decision was a backside covering exercise in order to avoid being drawn into the multi-party action against Schering and Wyeth, which make the pills in question. In the past, the CSM has been joined as a defendant in suits like these. If that were true, the government would be leaving itself even more vulnerable to lawsuits.
The question isn’t why it acted this way, but what took it so long. Pill manufacturers have admitted all along that thrombosis is a major risk. In some early studies, some combinations caused thrombosis in 9 out of 1000 pill takers. These dangers have been minimized, as makers claimed newer formulations were safer.
It’s time to admit that there is no such thing as a “low-dose” way of altering your entire body chemistry.