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A brave decision Minister, very brave

The report highlights a host of failures that hamper the development and approval of medicines for pregnant women. They range from the exclusion of pregnant women from clinical trials and poor information on existing medicines to woeful funding of pregnancy research and a fear of legal action if treatments on trial prove harmful.

We have a couple of pharma research experts around here. Yes, it would be good to have more drugs to treat the pregnant. Yes, lowering the pregnancy death rate would be good. And yet, there is a reason we don’t test things on pregnant women. Most of those waving half limbs and flippers around are now in their 50s and above but thalidomide really did happen.

12 thoughts on “A brave decision Minister, very brave”

  1. Quite so, and for related reasons clinical studies of medicines in children are rare although a lot more is known today about paediatric pharmacology through anecdotal and experiential publications. Rapid advances in drug design and in particular gene therapy, is a real concern these days especially when it comes to use in children who can’t provide informed consent. We don’t want to see thalidomide type damage or any other such adverse outcome become an inheritable trait. We all want more data on which to risk assess the use of drugs in pregnancy and in children and much will depend on in vitro tissue culture testing and modelling coupled of course with appropriate clinical risk assessment, transparency and informed consent. Its not just a brave decision as you say, it’s a brave new world out there in drug design and development and the pressure on ethical committees will no doubt be growing.

  2. The Meissen Bison

    Granted that the guardian wouldn’t be the guardian if it didn’t find something to cavil at at every turn but this is beyond their usual standard of fat-headedness.

    New Drugs To Be Tested on Pregnant Women Before Trials on the Wider Population
    in tomorrow’s guardian.

  3. Is the Guardian attempting to define “women?”

    The advantage of being a Guardian journalist is that you don’t have to fork out the couple of wheelbarrows of money to take out a full-page advertisement proclaiming your stupidity. You get a byline and some cash instead.

    Well played Meissen Bison well played.

  4. “the exclusion of pregnant women from clinical trials” is a failure?

    “Just sign this waiver of your right to sue us if we turn you baby into a heffalump or chimera and you’re good to go”.

  5. Using a historical example.
    A new virus is identified that affects a sub set of the population (elderly infirm) with severe outcomes for a small proportion of the sub set.
    A vaccine is proposed and tested on a different subset of the population (largely males 25-40). The trials are unblinded before stage three trials even began.
    Medicinal cures are banned on the grounds that their efficacy is merely anecdotal. No trials of these medicines, already known to be safe, are funded.
    The new vaccine is rolled out, initially to the vulnerable population and later to everyone, including pregnant women and children. A blanket indemnity is offered to the drug company.

    Sound familiar? Where was the ethics committee when all this was going on?

  6. philip

    Under the Online Safety Bill, your comment has just been removed as damaging and harmful fake news. Other comments too. Not yours Otto, you’ve received extra credits and that’s now enshrined in law.

  7. Interesting to see the Guardian talking about ‘unintended and grave consequences’.

    I remember seeing those consequences predicted at the time. Of course it was a John W Campbell editorial.

  8. True ANNRQ.

    It occurs to me that there is a simple solution to this problem. All the anti-Roe vs Wade Supreme Court judges are assassinated. By terrible Trump, egged on by Puke the Pervert of course.

    Biden the Beautiful replaces them with those who have the right opinions. And they add an amendment to Roe pointing out that pre-persons from conception up to the age of five, say are not really human and may be given the chop at their parents whim.

    Thus any pregnant woman can sign up for drug tests by assigning to the pharma company the right to dissect the worthless bits of flesh she’s about to produce.

    The Guardian, the woke and all decent people will cheer and rejoice. And the problem will be solved!!!!

  9. Bloke in the Fourth Reich

    Several things going on.

    You can’t, usually, knowingly give experimental therapies to pregnant women, the fetus can’t consent (yes, this turns into the entire quagmire about parental consent and responsibility etc).

    Many drugs are simply never going to be targeted at pregnant women, who form at any one point about 1/100 of the population. That’s already getting into territory where it gets hard to do trials of any drug at a scale useful for reliably determining such specific safety effects.

    In large scale trials there are usually some pregnancies, assuming women of the appropriate age are recruited. They are followed closely (treatment is always terminated upon notification of the pregnancy).

    Patients drug use (especially for treatment of chronic conditions) rises inexorably with age, as the likelihood of pregnancy falls inexorably. This rules a lot of drugs out from needing the research, let alone being able to do it in the context of a clinical trial*. Things for movement disorders don’t need pregnancy data. Conversely, things for multiple sclerosis do.

    Most pregnancy data comes from post-marketing surveillance. It is looked at pretty closely. IMX the elective termination rate is pretty high, which doesn’t add much useful information.

    Restrictions are high and precautionary, but often solidly needed. I know a woman (not Europe) on minoxidil for hypertension (leftoids should come along and smear it as being for bald men), for the mere risk of pregnancy. Women intending pregnancy can’t take most modern first-line antihypertensives. I would be interested in comment by the GPs of this parish on the attitude in the UK to ACEi/ARB use in young women.

    *: This didn’t stop similar legislation around 15 years ago requiring pediatric studies for everything. It was enthusiastically enforced for a long time. One of the more ridiculous things I have ever done was arguing that a pediatric trial in colorectal cancer was a stupid idea as there are single digit case numbers worldwide every year. Acutally, the ridiculous thing was losing the argument. Watch out for the “pregnant persons drug research directive” coming to a supranational agency near you some time soon. And pregnant people failing to sign up for all the trials.

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