Perspective: NIH should withdraw funding for research on cannabis use during pregnancy

An NIH-funded study at the University of Washington is intended to determine whether there are adverse effects of cannabis use by pregnant women on infants.

No, this is not fake news. Researchers at the University of Washington have received a grant of $200,000 from the National Institutes of Health, US. National Institute of Drug Abuse, to study the effect of marijuana use during pregnancy. The "Moms + Marijuana Study," or "Olfactory activation and brain development in infants with prenatal cannabis exposure " co-led by radiologists, Dr. Natalia Kleinhans and Dr. Stephan Dager, intends to track the marijuana use of pregnant women from the first trimester throughout pregnancy and then scan the infants' brains at six months to see whether it had any effect.

Although the researchers purportedly intend to study mothers who are using marijuana anyway, they are also being asked to refrain from using alcohol, tobacco, or other drugs and will undergo drug testing to ensure that they are only using marijuana and are using it regularly. Women will be paid $300 for "completing all parts of the study."

Under 45 CFR 46, the National Institutes of Health must carefully review all "human subjects research" requests, with particular attention under Subpart B for "Pregnant Women, Human Fetuses and Neonates Involved in Research." Specifically, the NIH must consider under Section 46.204(b), "The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal, and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means."

This study is intended to determine whether there are adverse effects of the use of cannabis on infants. There is no claim in the abstract that there is a benefit to the developing fetus aside from any secondary benefit of the mother's potential reduction in morning sickness. The long-term effects on infant development remain unknown. Realistically, the best-case scenario is if the baby develops normally to the point of matching the "control group" that was not exposed to cannabis. At worst, they might be born underweight, have cognitive or behavioral disorders, or physical brain abnormalities identified in imaging studies, or even fail to survive.

The abstract itself notes that "prior research also likely underestimated potential risks of cannabis use during pregnancy because modern strains are 3x more potent than they were 30 years ago" and acknowledges that babies may be born underweight as a result.

Additionally, by completing the study at six months, researchers may miss long-term cognition and behavioral issues that could arise and might create a false sense of safety. To date, all medical research has indicated that pregnant women should avoid all kinds of harmful substances during pregnancy to avoid harm to the babies.

In requiring mothers to use marijuana at the risk of losing the $300 promised for the study, and creating a risky situation with no upside for the infants, the study appears to run afoul of the human subjects research regulations. Mothers might feel pressured to act against their infants' apparent best interests and complete the study.

The budget period for the project is February 1, 2019 through January 31, 2020. It is possible that the NIH could withdraw funding under section 46.123 if the Federal agency finds that the institution has materially failed to comply with the terms of the human research policy. The NIH should revisit, and if necessary, revoke the grant.

This article was written by Michael Peabody and originally appeared on the ReligiousLiberty.TV website.

Image courtesy of ReligiousLiberty.TV

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This is a companion discussion topic for the original entry at http://spectrummagazine.org/node/9709

So, what is the real reason for thinking that the NIH should withdraw funding?

I could postulate one of two different scenarios. The first, which is the most generous, is that the research will result in the birth of children that have been exposed to cannabis being used by the mother during pregnancy. This can create a moral hazard, in that the child may not be otherwise exposed. The second is born out of concern that the research may find no particular harm is caused, thereby providing fodder for those who support legalising cannabis use.

The argument could be made that no mother is going to take up cannabis use for a measly $300. They are already using it. By entering the program, they give up on a whole lot of other stimulants, which should have some counterbalancing benefit for bubs.

We don’t live in a perfect world. It is better to know what the impact is than to have a collective lack of knowledge. I question whether there are better ways to gain this knowledge, such as testing on mice. Maybe this has already been done, and this study is an expansion of what has been learned to date. Whatever the reason, I am in favor of research that establishes real knowledge, with appropriate controls, over guesswork.

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This has more to do with politics than research. Ask any OB or psychiatrist what they tell their patients regarding pregnancy and cannabis use. No need to squander $200,000.00 on a question whose answer is well known. This would be similar to paying someone to research EGW books on questions whose answers are already known and ONLY available in the Bible.

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Since I work in a clinic system and I know we have pregnant women using marijuana (this is eastern Oregon), it would be helpful for us to have better information about the effects of what they are already doing. It may be that similar types of studies have been done regarding alcohol, tobacco, and excess Twinkie consumption during pregnancy. More information is good.

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With the way cannabis has been allowed to be used over the past several
years it seems like there would be quite a number of children of different
ages whose mother used cannabis smoking or in “brownies”.
Of course there ARE a number of different “chemicals” in it.
If there is some weird thing show up, it would take more sleuthing to
discover that.
One can get cannabis without THC. But that is processed.
[there might also be pesticide residue on some cultivated cannabis plants]

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Just more of the inexorable NORMLization …

The State Of Georgia and I assume every other state has a hospital devoted to the seriously mentally retarded and physically handicapped. The history has demonstrated a vast abuse of a variety of substances. The physical and mental deformities are beyond belief. Far more profitable would be to study the prenatal history of these victims. My limited contact suggests young unmarried girls on a variety of “trips”.

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I think likely they will ultimately do both and compare empiricle findings.
Maybe a little like SDA conscientious objector “white coats” medical Guinea pigs back during draft days. But here, the fetus has no choice. He/she is a victim of their mothers protection. Tough guestion… for an already user. If found to be damage, should the state be complicit in a crime?

Carolyn, do you work for a mental health clinic and do they have staff psychiatrists on board?

Just curious.

This is a very strange research being proposed. At this point in history, do we really need more info on this issue? I understand, since those women are already doing it, and nothing will stop them, some research may be helpful to increase the info on damage quantification - just for the sake of accumulating more info. But, still…

Shouldn’t those women actually be prosecuted for inflicting damage to the new human being they are forming?

I support the use of cannabis for medical purposes. It’s been proved beyong any doubt that in some critical cases, this is the only substance that can alleviate a person’s pain/suffering. But, again, in a society where alcohol legal, what’s the point of criminalizing marijuana? Alcohol is way more damaging to the consumer and to society anyway. But the lobbyists, ahhh the lobbyist… they are really powerful in buying politicians who can then easily make ilegal to become legal…

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We tried banning alcohol. My aunt had me picking dandelions so she could make wine. The smell alone was a crime. The Capone tribe had a hideout two miles from EMC. Our neighbor, a cabinet maker, did well doing work on their spread. He Found them charming, so he said.

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It seems to me that it is better to gather what knowledge we can from pregnant users who are determined to use cannabis whether or not anyone is studying them. The upside is that these same mothers would be swearing off other decidedly harmful substances during the study period. The NIH should be encouraged to implement safeguards against incentivizing mothers to use cannabis during pregnancy who would otherwise have decided NOT to use cannabis during that pregnancy. Also, the NIH should be encouraged to fund follow-up studies that will observe possible long-term effects related to the current research study groups. Overall, I can’t imagine that $300 is enough to garner anyone’s interest to participe in the first place.

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This study is very flawed. It used to be difficult (probably still is) to use human subjects in research when they aren’t being subjected to dangerous chemicals. But this can only hurt newborn babies by exposing them to chemicals while they are in the womb and giving them a rough start to life.

Poor women will be more likely to participate than affluent women and drug use of this nature tends to affect the poor disproportionately.

It may not incentivise mothers who weren’t doing to use pot anyway but it does not encourage them not to use pot.

I’m all for medical and even recreational pot because of freedom of choice. But I’m not for taking that freedom of choice away from little babies who will be born harmed by some way. Even if a child loses 1% of his or her capacity for success in life, life is already hard and this will be worse for them than if there was no study of this kind.

Sacrificing the health or even lives of some for knowledge is what happened in 1930s Germany. There is no way this meets human experimentation guidelines. Unbelievable.

Gramoxone, aka “paraquat”?

It is a wonderful thing, isn’t it?

Well, that’s just the thing. Is there damage? Perhaps we already know, but the funding of the study suggests we don’t.

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Tom –
Heard about dandelion wine mentioned by adult relatives when a kid, but
not sure they knew anyone who made it.
Dandelion leaves are so bitter, can’t imagine what the wine would taste like.
I guess if one is desperate for “alcohol” one will use anything. Even the
poison alcohol in aftershave, etc.
The adults did talk about people making “home brew” at home during prohibition.

Yes, quite well verified. Given that 4% of pregnant women self reported chronic cannabis intoxication, some issues have been identified. When combustion is used to vaporize the active compound, the health effects are more deleterious than cigarettes, partly because of the combustion temperature and the higher percentage of the cannabinoid oils. Cannabis use also is associated with concomittant alcohol use, which often creates synergistic increase of all effects.

Vaporization temperature required for inhalation administration is significantly lower than combustion, suggesting that, if tested properly, the health damages may be result of burning and not due to the drug itself.

Of course there is also the question whether blood levels of THC which initiate the desired psychoactive effects might also cause other health problems, particularly in developing adolescents (there are known problematic effects, including gynecomastia, cognitive development, emotional elements, apathy).

Effects in utero THC exposure may produce changes in certain hormones by inhibiting prolactin, growth hormone, and thyroid stimulating hormone secretions as well as stimulating the release of corticotropin. Low birth weight, STM and long term memory retrieval, increased childhood leukemia, as well exhibiting problems in planning, integration, and judgment has been associated with maternal to fetal cannabis transmission.

It is important to study these issues, but the study proposed seems to be premature and ill advised.

What issues? I wonder then why there is a need for a study, which suggests we need to know more.

I don’t think kids under about 25 to consume pot. I’ve read several studies that it harms their developing brains - or at least halts certain kinds of development - which then can never be reclaimed later. Better they drink and smoke, probably. At least that won’t really rot your brain.

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I work with a system of Federally Qualified Health Centers, with family practice medical, dental, and behavioral health services (but sadly, not psychiatry - so very hard to find in southwestern Idaho/Eastern Oregon). We love our LCSW’s and Counselors, they are wonderful! Our pediatrics clinic does use telemedicine for a psychiatrist in Portland though.

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