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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  8 comments for “Experimenting on the Vulnerable

  1. September 4, 2019 at 9:27 am

    This dreadfully thought-out research is unethical, immoral and unjustifiable.

    Surely it also must be illegal?

  2. Pamela McColl
    September 3, 2019 at 6:42 pm

    If you disagree with federal funds going to a study that recruits pregnant women who are frequent marijuana users throughout pregnancy – write to the director of NIDA and tell her – here is her email
    [email protected]
    Dr. Nora Volkow director NIDA.
    The Surgeon General’s advisory of August 2019 is all we need to make our case that this research is not necessary and therefore can not be done under the rules of the National Research Act – the act that governs human subjects in research.
    We have filed complaints with the Office of Human Rights, the World Medical Association, the American Medical Association, the University of Washington, the State Child Protective Services Division, the Governor of Washington, and with the White House. Time to shut down this study and protect these baby’s human rights. Have your say and join a growing
    number of citizens, and doctors who find this study in a word “shocking”.

  3. September 1, 2019 at 10:05 am

    Appalling.

    Some even think it could be “the new thalidomide”: https://www.ddponline.org/2019/05/28/health-effects-of-marijuana/

    • pAMELA MCCOLL
      September 3, 2019 at 6:37 pm

      Dear Jane

      Reach out and help us shut this study down – and get the $200,000 of federal funds returned to NIDA – here is the email for the director of NIDA Dr. Nora Volkow write her today – thanks
      [email protected]

  4. Sir Lance-a-lot
    August 31, 2019 at 10:14 pm

    “… the normal rules of medication approval do not apply to marijuana.”

    Why should they?

    Marijuana is a naturally occurring plant, not some newly invented molecule from Big Pharma.
    It would make just as much sense to require approval for broccoli.

    I’m not saying that I think smoking weed is a good idea. In fact, I don’t, at least not for anybody who has any need to think, but there was never any reason for the government to make it illegal, and there is no reason to require its approval for any use.

    “Medical marijuana” is a huge distraction for the medical, legal, and patient communities, which draws everyone into a whirlwind of meaningless activity and energy wastage. If someone wants to get high, God bless ’em, so long as they’re not my accountant or my neurosurgeon. We in the medical community should have nothing to do with the wacky weed – using it should be a matter that is solely between a person and Mother Nature.

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    • Pat
      September 1, 2019 at 8:20 am

      Amen Lance. The damned do-gooder, busybody government should have no say in this.

      And I strongly suspect broccoli has killed far more than pot, if only from the smell and the pretentiousness. Hopefully someone will be willing to fund that study.

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      • Sir Lance-a-lot
        September 1, 2019 at 12:06 pm

        “Hopefully someone will be willing to fund that study.”

        You’d never get it past the ethics board.

  5. Steve O'
    August 31, 2019 at 1:50 pm

    The VA allows unproven and unapproved treatments for Vterans. It is based on the assertion made by quackmakers that their treatment is safe.

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