Drugmakers Conceive Fewer Meds For Pregnancies
9 CommentsBy Ed Silverman // January 22nd, 2008 // 7:11 am
Pregnant women are being forced to take potentially dangerous drugs because pharma isn’t developing medications proven to be safe for unborn babies, according to a study in PLoS Medicine, News.com.Au reports.
Seventeen of the drugs under development for use are actually improvements to existing meds, the study shows. And that amounts to less than 3 percent of the 660 drugs in the pipeline for cardiovascular ills and half those in development for a rare condition called amyotrophic lateral sclerosis. Development also falls short of the 34 drugs for amyotrophic lateral sclerosis, or Lou Gehrig’s Disease, which affects between two and five people in 100,000.
By contrast, 500,000 women die during pregnancy worldwide each year and more than 7 million babies die before or shortly after birth, mostly in the developing world, the researchers said.
“The market has failed pregnant women,” Nick Fisk and Rifat Atun wrote. “Seventy-five per cent of pregnant women are taking at least one drug for which safety data are unavailable…The paucity of obstetric drugs impacts not only the resource-rich countries, but also affects the far greater disease burden in resource-poor countries.”
This is partly because regulators and aid organizations have neglected a sector that doesn’t provide drugmakers the financial incentives to pursue new treatments, they said.
The researchers, in their analysis, reviewed a database of drugs listed as under development on company Web sites, at conferences, in medical journals and as part of registered clinical trials. They found that, since 1980, more than 37,000 drugs have been listed as under development but only atosiban, carboprost and carbetocin have been licensed for pregnant women.
Ferring Pharmaceutical sells atosiban and carbetocin as Tractocile and Duratocin, respectively, while Pfizer markets carboprost as Hemabate. “In the United States, no licensed drug is available for pre-term labour,” the researchers said.
Industry reluctance to test drugs that could cause birth defects and spur big lawsuits, a small market size for conditions affecting pregnant women, and a regulatory system that allows off-label use are some reasons, they added. Solutions could include financial incentives to spur new drug development and the use of not-for-profit organizations to carry out research, they said.
“Given the unacceptably high number of maternal and perinatal deaths each year, it is high time to address this failure,” the researchers said.
Nathan
I could be wrong, but one major problem with developing drugs in this area is clinical trials. What women are willing to take on the (slight) risk of deformity or miscarriage in order to test out a new medication? Unless it’s a life-threatening condition, I don’t know that you’ll find pregnant women to enroll in the clinical trial.
Fetal development is something we know very, very little about. Even chemicals as seemingly innocuous as caffeine have been shown to be dangerous to a fetus. Is the life of a baby something we really want to risk in order to improve the health of the mother? In the case of pediatric drugs, the parent can give “informed consent†for the child. This is because the real interest at heart is the health of the child. But who can give “informed consent†for the risk to the unborn fetus when it’s the MOTHER’S health at stake? It seems like a conflict of interest to me…
I’m sure people have thought through those issues – but it’s bound to be very, very hard to run clinical trials in pregnant women.
Lisa Van S
Nathan,
“Fetal Developement is something we know very, very little about”.
That is a Very, Very scary insight on your part. Im sure OB/GYN’s., would disagree, let alone the “MILLIONS” of women who are, or, were pregnant. Common sense alone tells you that whatever a pregnant woman ingests, is also ingested by the Fetus/Baby.
FDA’s Med Watch alone, will give you an insight of how devastating the effect antidepressants have on the unborn child, withdrawal and death are just two that come to mind.
FDA “AERS” Report:
http://www.psychdrugdangers.com
Nathan
OB/GYNs are very aware of the PHYSICAL development of the fetus. What we know very little about is the molecular signaling pathways that stimulate the fetus to grow the way it does. It’s these signaling pathways that we PURPOSELY interfere with for drug development. Interfering with these pathways can have completely unintended and unpredictable consequences on the development of a fetus. Remember that the fetus is actively utilizing many, many pathways that are turned off (or silent) in fully grown humans.
It’s a very tough risk/benefit analysis. Is the (potential) benefit to the mother worth the (potential) risk to the fetus? Once the baby is born, at least the risk and benefit are both to the same patient. That makes the analysis a little easier.
Of course, one could counter this argument by saying that the baby also benefits because without treatment he/she may have an unhealthy (or dead) mother…
RB Murphy Ph.D.
As someone who has been in early-phase pharmaeceutical discovery and development for some time, it’s IMHO simply a risk management issue.
First, extensive preclinical reproductive toxicology and cytogenetic studies above and beyond what normally required would need to be done and need to be totally clean. Most early candidates would probably fail this and this would only be known after a year(s) or more of work at a substantial cost. Time is money.
Second, if a drug comes (years later) to market the potential for tort suits is inordinate, whether or not a drug actually has caused a problem. Unfortunately, there’s legal prescident for “junk science” getting into the courroom. This can work either for or against the plaintiff or company, but it’s a wild card in principle. If anyone doubts this look up the history of bendectin ( a mild sedative used in pregnancy) v. Merrell Dow (1993)
Lisa Van S
Nathan,
Many counter arguments can be made,.. Does a Woman/Mother benefit from antidepressant use for mild/situational depression?.. Mild anxiety due to becoming a first time Mother.
Flip Side; Their is no greater pain on the face of this earth, then the loss of a child. And no amount of Medication will ease that pain.
Times sure have changed, Back in my Pregnancy days, women didnt ingest Pharmaceticals, and OB’s didnt Prescribe them.
I am sure we both can agree, that this can be a highly sensitive issue..
Lisa Van S
Doc Murphy
Bendectin,.. Is that the same as Thalidomide? Accutane can be seen as another problem for Pregnancy.
Jack2
Everyone knows about this problem but no one has a good solution. It’s similar to the problems with prescribing meds to pediatric patients.
Is it ethical to test these meds in pregnant women pre-approval? In my opinion, the best solution is to (financially?) encourage prescribers to report the outcome (good or bad) of any off-label medication use to the company or the FDA, rather than systematically encourage testing meds in pregnant women.
ol cranky
Lisa:
bendectin isn’t thalidomide, it’s a combination of B6 & doxylamine. [Thalidomide, for the record, was never approved in the US for use in pregnant women; since the fiasco with it's use during pregnancy, it was an uphill battle in the 90's to get it approved for the limited and legitimate, approvals it has received since] Accutane is among the nastiest of teratogens, and has well documented teratogenic effects long after the last dose which is why females are cautioned about the absolute need to prevent pregnancy during and for a few years after use of the drug. While thalidomide and accutane get the most bad press there are a lot of other drugs on the market that have significant teratogenic effects (for examples, ARBs are pretty safe for adults but they do a lot of damage to a fetus).
Clinical trials are very difficult in pregnant women because you do have to worry about what crosses the placental barrier and the effects during embryonic/fetal development of the compound as well as any and all metabolites. In trials not meant to expose pregnant women, any person born after exposure in utero has legal standing to sue the company for any injury they feel they’ve experienced from exposure to the product. I’m sure there’s concern that, even where the mother consents to exposure while pregnant, that any bad press or lawsuit isn’t worth the effort to develop a drug. Companies were resistant to allowing women of cbp (using an acceptable form of contraception) to be included in trials as recently as the 90s for these reasons.
Lisa Van S
Ol Cranky,
Very informative,.. Thank You