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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.
(Score: 1, Insightful) by Anonymous Coward on Thursday July 26 2018, @02:27PM (6 children)
What I understood from it is they decided to abort the trial before the mortality rate became statistically relevant. However they had indicators there was a chance it would.
I feel like the article is a bit sensational. Could anyone with more knowledge then me shed some light on this? Although I have to admit I giggled at "abort the trial".
(Score: 0) by Anonymous Coward on Thursday July 26 2018, @02:34PM (3 children)
Planned Parenthood are already looking into offering prescription free viagra for all.
(Score: 0) by Anonymous Coward on Thursday July 26 2018, @02:44PM (2 children)
[citation needed]
(Score: 1, Insightful) by Anonymous Coward on Thursday July 26 2018, @03:23PM
^ doesn't get the "joke" [americamagazine.org]
(Score: 0) by Anonymous Coward on Thursday July 26 2018, @07:46PM
-1 No Sense Of Humor
(Score: 2) by mobydisk on Thursday July 26 2018, @05:39PM (1 child)
They probably didn't need to prove that the drug was killing babies, they just needed to prove that it wasn't saving them at a statistically significant rate. Ex: If the chance of losing the child went from 50% to 49%, who wants to bother with that drug?
(Score: 2) by bob_super on Friday July 27 2018, @01:40AM
Daddy wants her to.
(Score: 2) by DannyB on Thursday July 26 2018, @02:58PM (8 children)
From TFA. (not that I would want to be labeled as one who would look at TFA)
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!
Infinity is clearly an even number since the next higher number is odd.
(Score: 4, Interesting) by Freeman on Thursday July 26 2018, @04:06PM
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)
> 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)
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)
Notice that "internal" does not specify the pathway ...
(Score: 0) by Anonymous Coward on Thursday July 26 2018, @05:25PM (1 child)
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
"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
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
My understanding is that there was also a lack of benefits.
(Score: 5, Interesting) by fadrian on Thursday July 26 2018, @03:03PM (7 children)
It's a shame, but that's how medicine advances. Given that there was no treatment for the original condition, it was worth a shot. It looks like the trial system worked (sort of) as designed - try something, if it doesn't work, stop it as quickly as you can.
The only issue I might see is that 11 deaths seems a bit high before stopping the trial. You'd think that 3 or so would be enough to halt it, but I guess you'd have to know the original trial population and they did have to determine causes of death, decide whether or not the deaths were due to the drug, etc. It might take them a while to get the trial stopped, too, depending on its size and the numbers of practitioners involved.
That is all.
(Score: 2) by DannyB on Thursday July 26 2018, @03:05PM (5 children)
I think they said 93 women got the drug, and 90 women in control grope received placebo.
Infinity is clearly an even number since the next higher number is odd.
(Score: 1, Touché) by Anonymous Coward on Thursday July 26 2018, @03:21PM (4 children)
heh, freudian slip
(Score: 0) by Anonymous Coward on Thursday July 26 2018, @03:29PM
Most likely wearing hospital nightshirts and not your moms panties!
(Score: 2) by DannyB on Thursday July 26 2018, @03:38PM (2 children)
You obviously haven't seen my posting history.
Infinity is clearly an even number since the next higher number is odd.
(Score: 3, Funny) by bob_super on Thursday July 26 2018, @04:27PM
Controlled groping, synchronized groping, artistic groping ... what a great idea for raising viewership at the 2020 and 2028 Olympics!
Gimme a minute to Tweet someone, and he'll make it happen!
(Score: 3, Touché) by Bot on Thursday July 26 2018, @04:39PM
> You obviously haven't seen my posting history.
the autocorrect has seen your posting history though nudge nudge wink wink say no more.
Account abandoned.
(Score: 0) by Anonymous Coward on Monday July 30 2018, @05:51PM
what a blind whore you are. big pharma apologist. there's probably a simple, natural way to avoid this condition and for the ignorant/unfortunate who still develop the condition, there's probably a simple, natural, completely safe treatment. Instead, the monstrous pieces of dog shit kill 11 babies. i would have no problem executing these stupid motherfuckers.