Stories
Slash Boxes
Comments

SoylentNews is people

posted by chromas on Thursday July 26 2018, @02:20PM   Printer-friendly

Babies die after mums given Viagra in Dutch trial

A Viagra in pregnancy trial has been urgently stopped after 11 newborn babies died. Women taking part in the Dutch study had been given the anti-impotence tablets to improve growth of their unborn children because they had poorly developed placentas.

It appears the drug, which promotes blood flow, may have caused lethal damage to the babies' lungs. Experts say a full investigation is needed to understand what happened. There is no suggestion that there was any wrong-doing.

Earlier trials in the UK and Australia and New Zealand did not find any evidence of potential harm from the intervention. But they also found no benefit.

[...] Foetal growth restriction caused by an underdeveloped placenta is a serious condition that currently has no treatment. It can mean babies are born prematurely, with a very low birth weight and poor chances of survival. A medication that could improve weight or prolong the time to delivery could have significant advantages for these very sick babies.


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 2) by DannyB on Thursday July 26 2018, @02:58PM (8 children)

    by DannyB (5839) Subscriber Badge on Thursday July 26 2018, @02:58PM (#713136) Journal

    From TFA. (not that I would want to be labeled as one who would look at TFA)

    Twenty babies developed lung problems after birth - three in the placebo group and the rest in the treatment group.

    If three babies from the control group also developed the same problem, then would it be reasonable to assume that three from the experimental group could also develop the same problem without having had the drug?

    Even though six times the number of deaths occurred in the experimental group, is 20 out of 93 cases a large enough sample size?

    Is it possible to study this in animals before trying it in humans?

    But we let McDonalds test its new concoctions on humans without animal trials!

    --
    People today are educated enough to repeat what they are taught but not to question what they are taught.
    Starting Score:    1  point
    Karma-Bonus Modifier   +1  

    Total Score:   2  
  • (Score: 4, Interesting) by Freeman on Thursday July 26 2018, @04:06PM

    by Freeman (732) on Thursday July 26 2018, @04:06PM (#713181) Journal

    While, it could have nothing to do with the drug. They can't ethically, assume that. They're trying to help, not make matters worse. A 6x increase in deaths by doing something as opposed to doing nothing, means it's better to do nothing. Same size matters, but they are doing human trials. Not, lab rat trials.

    --
    Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"
  • (Score: 2) by bob_super on Thursday July 26 2018, @04:23PM (4 children)

    by bob_super (1357) on Thursday July 26 2018, @04:23PM (#713188)

    > But we let McDonalds test its new concoctions on humans without animal trials!

    McDo does a lot of internal human testing on their new products before releasing them. Clearly a lot more than the vitamins and supplements guys.

    • (Score: 0) by Anonymous Coward on Thursday July 26 2018, @04:31PM (3 children)

      by Anonymous Coward on Thursday July 26 2018, @04:31PM (#713196)

      I _would_ certainly hope that McD does internal testing on its products, and not just external ... if a new Hamburger were safe to apply to the skin, that certainly would not be a conclusive sign of it being delicious, or edible.

      • (Score: 2) by bob_super on Thursday July 26 2018, @04:45PM (2 children)

        by bob_super (1357) on Thursday July 26 2018, @04:45PM (#713212)

        Notice that "internal" does not specify the pathway ...

        • (Score: 0) by Anonymous Coward on Thursday July 26 2018, @05:25PM (1 child)

          by Anonymous Coward on Thursday July 26 2018, @05:25PM (#713234)

          Even with that in mind: shooting Hamburgers at you belly with a 155mm howitzer is not a recommended method of ingestion

          • (Score: 4, Informative) by bob_super on Thursday July 26 2018, @05:33PM

            by bob_super (1357) on Thursday July 26 2018, @05:33PM (#713240)

            "I checked their feedback sheets, after washing the blood, and nobody complained about the taste"

  • (Score: 4, Interesting) by exaeta on Thursday July 26 2018, @05:45PM

    by exaeta (6957) on Thursday July 26 2018, @05:45PM (#713247) Homepage Journal

    A 5 fold increase at that level IS statistically significant. Maybe not to six sigma or whatevet level of certainty you want.

    Let's apply the Maximum Likelyhood Method for analysis:

    93 test subjects in group A.
    17 true results.
    76 false results.

    90 test subjects for group B.
    3 true results.
    87 false results.

    so therefore for group A we have the probability equation:
    (p)^17(1-p)^76 / (93 choose 17)

    We can omit the last bit for finding the most likely value of p given that it is constant (but will need it if we want exact values).

    Therefore for group A the p-value most likely is 0.18280.

    For group B the value most likely is given by maximizing:

    (p)^3(1-p)^87 / (90 choose 3)

    p is most likely around 0.03333 ( by maximization).

    Now we can perform cross substituition:

    ((0.18280)^17(1-0.18280)^76 / (93 choose 17))/((0.03333)^17(1-0.03333)^76 / (93 choose 17))

    Result is 1.05...

    Therefore there was only a 5% increase in likelihood...

    So not statistically significant? Maybe! but we need to substituite the value in the control group too.

    Control distribution is:
    (p)^3(1-p)^87
    so:
    ((0.03333)^3(1-0.03333)^87)/((0.18280)^3(1-0.18280)^87)

    ≈ 13,500

    13,500 * 1.05 ≈ 14,100

    Therefore there is about a 1-in-14,100 chance the result was caused by random variation. Good idea to stop the study, I think.

    --
    The Government is a Bird
  • (Score: 2) by dry on Sunday July 29 2018, @04:58AM

    by dry (223) on Sunday July 29 2018, @04:58AM (#714239) Journal

    My understanding is that there was also a lack of benefits.