Experimenting on the Vulnerable

It wasn’t just Nazi Germany that conducted experiments on vulnerable people. Right here in America, the infamous Tuskegee study withheld treatment for syphilis was so researchers could study the natural history of the disease, allowing people to die so they could study their autopsies.  Thankfully, we’ve advanced. The World Medical Association developed the Helsinki Declarationprinciples of ethical research to protect vulnerable populations. 

Apparently, Natalia Kleinhans, PhD and the University of Washington did not get the memo. Using the cutesy title “Moms + Marijuana,” they plan to study the effect of marijuana on the offspring of pregnant pot users. Encouraging women to smoke pot to see if it impairs their children seems like just the type of research that the Helsinki declaration was meant to abolish. Although the researchers don’t provide marijuana to the pregnant subjects, they don’t do much to discourage use either. In fact, according to the AP report, the University only agreed to give a handout stating that pot may be bad during pregnancy in response to complaints about the study.  

The study’s website itself is misleading. They begin by asking the question, “Isusing marijuana to alleviate nausea safe for your baby?” However, the website states that a woman must actually be a ‘frequent’ user of marijuana to qualify for the study. The consent form (obtained only after a study critic filed a Freedom of Information Act request) doesn’t mention morning sickness at all.

They had good reason to hide the consent forms from public view. It does not include any recommendation to stop using marijuana during pregnancy. They want their naive subjects to think it is an open question as to whether marijuana is dangerous during pregnancy. If the researchers wanted to give full disclosure, they could have cited the FDA approved package insertfor prescription THC (Marinol) which provides the current knowledge. 

Studies have found increased “fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to the NICU, and stillbirth.” Animal studies are even more disturbing. “Exposure of pregnant rats to delta-9-THC … [may] result in abnormal patterns of neuronal connectivity and subsequent cognitive impairments …in impairment of motor function, alteration in synaptic activity, and interference in cortical projection of neuron development in the offspring.  … effects on cognitive function such as learning, short-and long-term memory, attention, decreased ability to remember task, and ability to discriminate between novel and same objects. Overall, prenatal exposure to THC has resulted in significant and long-term changes in brain development, cognition, and behavior in rat offspring”

Patients already get enough mixed messages about marijuana use during pregnancy. Two-thirds of Colorado pot shops recommend marijuana for nausea during pregnancy.Even the AP report about the U. of Washington study glorifies the use of marijuana by highlighting the anecdote of a businesswomen who found salvation from migraines and pregnancy-related nausea by using marijuana. Only towards the end of the story do we learn that the testimonial was provided by a pot shop owner.

Being a prudent physician, I hesitate before prescribing even a Z-Pak during pregnancy, yet Dr. Kleinhans thinks nothing of sanctioning the use of a lipophilic psychotomimetic drug that is known to cross the placenta and accumulate in fetal brain tissue.

Thirty-three states have legalized marijuana as a medicine for over 50 conditions without randomized controlled trials, showing that the normal rules of medication approval do not apply to marijuana. Apparently, the standard rules of medical research ethics don’t apply either. 

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