when drug trials go wrong

The Beeb continues to report on the condition of the six young men who participated in a drug trial and are in intensive care. There’s an accompanying article interviewing a bloke who was due to take part, where he speaks about the motivations and incentives that are behind why men take part in these trials. There’s often a lot of money involved, and it must be very tempting.

I say must be, because as a woman, my chance to take part in a clinical drug trial (the Phase I, experimental kind) is virtually nonexistent. Dave from Bristol clearly needs to know this (scroll down). The requirements are overwhelming sensible: young and healthy bodies required for the initial rounds. Women are considered more problematic than men because we could be pregnant, or might want to get pregnant at some point, and drug companies don’t want to get sued for impeding fertility.

This has always irked me. Firstly, anyone pregnant or at risk of pregnancy (that would be carried to term)–of course they shouldn’t do a drug trial. Common sense. But presumably there may also be effects on male fertility as unforeseen as those on female fertility from new drug treatments. I can’t comment on the degree of “informed” and “consent” in informed consent in these things, as, well, I’ve not taken part. But presumably this is an issue?

Secondly–and this is an issue that goes beyond gender–it’s representative of a deeply embedded conception of the young man as the default model, medically speaking. I got cranky at my doctor a few months ago when she couldn’t tell me if a consistent pattern of change in my cycle was linked to coming off a (very very common) drug. Fine, I thought, I can search PubMed and nyah to to the overworked NHS. There was not one mention of cycle change patterns beyond “a number of women reported changes to cycle length”. This, if I recall correctly, in a thousand-odd sample.
Anyhow: best wishes to the men and their loved ones. I wish the slightly hysterical tinge to some of the reporting was tempered by a statistic or two showing the number of drug trials per year and the percentage–which I am certain must be low–that result in serious adverse reactions.

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2 responses to “when drug trials go wrong

  1. Well said,i applaud your blog,mental health consumers are the least capable of self advocacy,my doctors made me take zyprexa for 4 years which was ineffective for my symptoms.I now have a victims support page against Eli Lilly for it’s Zyprexa product causing my diabetes.–Daniel Haszard http://www.zyprexa-victims.com

  2. I am currently particpating in a clinical trial in Japan, a very interesting experience. As you mention, women are not tested on and all my fellow participants are young men between the ages of 20 and 31. Shut in together for over two weeks, its a bit of a boys club, albiet a boys club requiring regular blood sampling, ECGs and other medical procedures. I’m writing a online diary about my experiences you can read at

    http://whitemice.wordpress.com/

  3. Cheers yugyug. Will be interested to see how it goes for you!

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