Poor Pregnant Women with Herpes Don't Get Meds, and Someone Notices
| Wed Dec. 6, 2006 5:03 AM PST
GlaxoSmithKline, in testing their herpes med, Valtrex, may have put women in harm's way. This according to Public Citizen, which, in the Dec 1 issue of Obstetrics and Gynecology accuses the pharma giant of withholding important medication from poor and minority women.
In a recent clinical trial 168 pregnant women were given a placebo rather than an alternative herpes drug, while the other 170 were given medication. This, despite the fact that research has shown that the drug and its generic, acyclovir, reduces risks associated with herpes and pregnancy (the virus can be fatal for infants who contract the disease at birth).
The study, which took place earlier this year and was funded by GlaxoSmithKline, enrolled more than 300 black and Hispanic pregnant women at Parkland Hospital in Dallas. The hospital serves a largely indigent population. Public Citizen's Dr. Peter Lurie is outraged:
"What I don't understand is how you can do a research study and conclude that a drug is effective and then stare a bunch of pregnant women in the face and withhold the very drug you've just recommended."
A doctor involved in the study, Dr. George Wendel, would not comment specifically on allegations that poor women were taken advantage of, instead saying that the study was designed and conducted "according to good research practices" and was approved by the hospital's ethics review board.
Continues Below
Continued From Above
Comments
I find it unconscionable that they would purposely refrain from giving this drug to poor and pregnant women, particularly when they know newborns can contract it at birth from their mothers. If any of these newborns acquires herpes from their mothers, the drug company should be held wholly accountable. If herpes is fatal to newborns, then this act of withholding this vital medication is akin to negligent manslaughter or worse.
And why would the study be performed only on black and hispanic women. If an ethics board was involved in the decision making process wouldn't the mere fact that no other races were included in this study be enough to raise eyebrows? Outrageous!!!!!!!
Question: The only way a child can contract herpes is if the mother is having an outbreak during labor and delivery. If a woman has had any prenatal healthcare, there is an obligatory test taken one week before delivery for herpes.If it's present, caesarian is mandated. Hence, a c-section is always performed to avoid this risk. Perhaps another quesion should be asked: Most people involved in controlled study groups are living in poverty or close to it. These studies are rarely performed on middle or upper-middle class because of the obvious dangers involved.
There's a reason that so many drug companies categorize their drugs as C of D--teratogenic, meaning potentially dangerous to a fetus because it crosses the placenta. Without controlled studies, there can be no way to determine if a drug is acceptable to take during pregnancy. My question isn't why were the women all black and Hispanic, but why aren't the drug companies more accountable and more forthcoming in the way that they test drugs. To put it personally, would you participate in a study that may or may not risk the life of your unborn child? Yes, acylovir has been proven to reduce the number of outbreaks of herpes. There is evidence that taking it at high doses can almost wipe the virus out completely. However, I have not read any studies on the risks of acyclovir in pregnancy. These women were undoubtedly paid to participate. I've gathered much anecdotal evidence that these "control groups" generally are populated by at risk people--those living in poverty, those who have other addictions, etc.
There's a bigger story here. Go after it. How do the pharma companies conduct their studies? How much do they pay? Are the results automatically skewed due to other factors? Start talking to the psychiatric community.
I couldn't find either of the articles linked to (perhaps because this was posted a few weeks ago?) but your article seems a bit confused or confusing. You write that these women were in a clinical trial to test a drug's effectiveness. Well, in such a trial one group is given the drug and the other is given a placebo. That is the only way to know if a drug is effective. It wouldn't be a valid study otherwise!
Is this what the "outrage" is about? Or there an issue of being denied the drug _after_ the study was over?
It's not very clear from what you have written.
Chad says:
And why would the study be performed only on black and hispanic women. If an ethics board was involved in the decision making process wouldn't the mere fact that no other races were included in this study be enough to raise eyebrows? Outrageous!!!!!!!
But was it? There were *more* than 300 women in the study. Were they all black and/or hispanic? It's not clear from this article.
An ethics board would review the process before the participants were recruited. If the hospital where they were recruiting has a specific demographic make-up, that would be reflected in the people involved.
Terry: Control groups in a study won't be any different than the groups recieving a drug because, once they are screened and qualify for a study, they are randomly assigned to either group. Any anecdotal evidence that control groups consist of "at risk" people would have to be justified by more evidence to be at all convincing.
Submitted by Lisa (not verified) on Sun Apr. 22, 2007 8:05 PM PDT.
Can I post this story to my blog at http://www.positivesingles.com/blog/I_pozgirl
I am collecting information about herpes and pregnancy there.
Well if their just in
Submitted by Mike M (not verified) on Mon Jul. 27, 2009 2:10 PM PDT.
Well if their just in testing stages do they want to give it to a pregnant person? Is that why they won't give it to them.... Their are lots of different STDs amongst other things that can complicate a pregnancy maybe they just don't think it's worth the risk of giving it to the mother when they just normally do a c section anyway.
