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To: DFG
The test subjects are to document their weekly marijuana use by sending photos of the drug’s packaging to the researchers. This is to give the researchers information about the total percentages of both tetrahydrocannabinol (THC), the active ingredient in pot, and cannabidiol (CBD), a non-active component that allegedly helps to alleviate certain pregnancy symptoms.

1. I do not favor this study in humans.

2. As a scientist, I can observe that the prospective study is not well-designed. Photos of the drugs' packaging mean little more than self-reported exposure. Without weekly blood testing, any observations and results mean little. The dose would be un-quantitative, at best. One other concern is the control arm, and whether-or-not they cheat.

It is unlikely that the proposed study can produce results to any satisfactory degree of validity.

(Opposing opinions invited.)

.

23 posted on 06/25/2019 6:28:02 PM PDT by Seaplaner (Never give in-never, never,never...except to convictions of honour and good sense. Winston Churchill)
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To: Seaplaner
Opposing opinions invited.

None here.

I would like to add that I find the IRB review process in this case highly questionable. Or did an IRB even review the protocol?

A keyword search of "marijuana pregnancy" in PubMed reveals 1402 articles already published. Some of the titles look alarming: for example, cannabis use alters cell growth and mitochondrial function. And the following abstract suggests that we are going to have a serious problem in a few years when children whose mothers used marijuana during pregnancy enter school:

Med Hypotheses. 2019 Mar;124:53-55. doi: 10.1016/j.mehy.2019.02.017. Epub 2019 Feb 4.
Cannabis use during pregnancy: Are we at the verge of defining a "fetal cannabis spectrum disorder"? Schreiber S1, Pick CG2.
Author information

Abstract
Cannabis is probably the drug most commonly used globally since ancient times. Following the trend of legalization of access to cannabis in several Western countries, its use has increased in North America over the past few years. In spite of warnings of the potential hazards associated with in-utero exposure to cannabis, approximately 10% of pregnant women in an American study reported using cannabis in recent years, and most of them on a daily basis. Significant effects of prenatal cannabis exposure have been found on children's sleep, cognitive functions (memory and scholastic skills), as well as on executive (frontal lobe) functions (reasoning, attention, impulsivity, and motivation), and affective (depression) and anxiety symptoms throughout the stages of development. Following the presentation of two case vignettes, we integrate the published information on outcomes of maternal use of cannabis during pregnancy on the developing fetus and the "soft" neurological deficits and neuro-behavioral disturbances manifested by them from early childhood and evolving to peaks in adolescence. Taken together, these data serve to define what we call a heretofore unspecified "fetal cannabis spectrum disorder".

25 posted on 06/25/2019 6:39:42 PM PDT by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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