fetaldex.org

issue: risks

 

For an update on what we know about risks since this page was written, see the home page.


The use of prenatal dexamethasone at issue is not FDA approved, and yet Dr. Maria New has long described this drug to prospective, vulnerable patients as “safe for mother and child.” (See our complaint to the FDA about this advertising.) In fact, this drug is recognized by many major medical societies as being extremely risky, rife with unknowns, and highly experimental. And it has been for years. Yet Dr. New has apparently recruited hundreds of pregnant women to this treatment, outside clinical trials, with the claim that it is safe, and then studied them later to see if it really is safe.


According to a recent article in Endo Daily reporting on the Task Force that produced the latest consensus to label prenatal dex experimental, dexamethasone “crosses the placental barrier and may affect the fetal hypothalamic-pituitary-adrenal axis. Prenatal use of the drug is associated [with] low birth weight, central nervous system effects, cleft palate, liver enlargement, a decrease in fetal beta cells and other negative outcomes in animals. The human literature suggests that prenatal dexamethasone carries a 1.7 odds ratio for orofacial clefts and decreases birth weight by about 0.5 kg.”


The Endo Daily article continues: “The task force was hampered by the lack of high-quality data. Of 1,083 studies originally identified [by the task force], only four met the quality criteria agreed upon by the sponsoring groups. [...] Side effects included stillbirth (odds ratio 1.27), malformation (odds ratio 1.51), maternal edema (odds ratio 1.83) and maternal striae (odds ratio 1.62). Outcome data on prenatal treatment are suspect. Most are derived from questionnaires, not from physical examination of the offspring. And because dexamethasone prenatal treatment is relatively new, no offspring have yet reached middle age where many problems can be expected to present.”


Claiming prenatal dex is “safe for mother and child” when all the major medical societies say it is experimental, when the data are so bad (see above), and recruiting patients to an experimental treatment with claims it is safe while studying years later (using questionnaires!) whether it really was safe?


This kind of behavior puts at risk pregnant women and their offspring. It puts at risk their bodies, and also their rights. It also puts at risk clinicians who are misled into thinking this treatment is standard of care when it isn’t. And it puts at risk medicine and medical science by engaging in behaviors that cause people to become actively (reasonably) suspicious of medical care and medical experimentation. This, in turn, ultimately will harm even more people.


Clinical trials are designed to ensure that; (a) people who are being experimented on know that they are being experimented on, are given the protections afforded to human subjects of research by the federal government and local institutions, including the rights to informed consent and to decline experimentation; (b) researchers can most quickly become aware of adverse affects, in this case harms to mothers and children, so that, if necessary, they can stop the experiment before others are harmed; and (c) the maximum amount of scientific data can be gathered from the treatments, so that those whose health and lives are put at risk for medical science at least can rest assured that the methods being used will maximize the scientific learning which may then benefit others.


So it’s important to remember here how many people are put at risk when experimentation like this is conducted outside IRB-approved clinical trials: mothers, their children, medical care providers, and people who may benefit from medical science. We are not being radical in suggesting that it is really inappropriate to administer prenatal dex for CAH outside of clinical trials. We’re in line with the medical consensus on this matter.


Note: It isn’t clear that any human research oversight board (IRB) should allow this drug to be tested experimentally for this use. See our page on the question of whether IRBs should approve experimentation with this treatment.



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(Written by Alice Dreger; copyright Alice Dreger, 2010)