Tag: mental-health

Is it Just a Bowl Of Cereal?

KristaSurprenantLeave a comment

Ethics in Medical Practices: Part 1

By Krista Surprenant

Quaker Oats Advertisement – 1901

Most of us have experienced a health kick at some point in our lives—reading nutrition information, counting calories, and tracking vitamin levels to hit the perfect daily intake. Maybe you’ve even looked up the health benefits of your favorite products. But have you ever stopped and asked yourself how those nutrient levels were determined?

For one brand, information on nutrient levels can be traced back ~75 years to a specific study done at The Massachusetts Institute of Technology (MIT)1. Prior to MIT’s experiments in 1949, studies showed an acid found in oats had a negative impact on calcium, iron, and phosphorus absorption, sparking debate around the nutritional value of oat-based cereals [1,5]. This raised consumers’ concerns about major brands such as Quaker Oats. In order to defend their product against competitors like Cream of Wheat, Quaker Oats funded MIT’s study to track iron and calcium absorption following cereal consumption [1]. The company hoped to demonstrate that their cereal did not reduce mineral absorption and was nutritionally comparable to Cream of Wheat [1,5].

To carry out this experiment, MIT needed volunteers, so they turned to The Fernald State School in Waltham Massachusetts [1,5].

In 1848, the Massachusetts School for the Feeble-Minded was founded by Samuel Gridley Howe with the goal of educating disabled adolescents to become high-functioning, independent individuals [6]. Students were taught academic, vocational, and personal skills, including sewing, housekeeping, music interpretation, and athletics [6]. Over time, the school expanded to house adults requiring custodial care and individuals with more severe disabilities. In 1888, Walter E. Fernald became superintendent of the school and shifted the institution’s philosophy towards a scientific framework rooted in eugenics [6]. Eugenics sought to promote “desirable” traits through selective breeding while eliminating “undesirable” traits—possessed by groups that included people of color, immigrants, and individuals with developmental or intellectual disabilities [6,7]. Those deemed “undesirable” were often institutionalized, including residents of what became known as the Fernald State School in 1925 [6].

During this same period, IQ testing became widespread, and children scoring below average were labeled “morons” or “intellectual delinquents” and frequently institutionalized without parental objection [6,7].

Fernald State School Dormitory for Boys

Due to the increased population of students admitted to the Fernald State School, the institution became overrun and underfunded [5,6]. Eventually, the school became home to 2,000-2,500 disabled and unwanted children who were, at the time, considered “not part of the human species” [5,7]. When it opened in 1848, the school’s aim was to provide students with a stable education and sustainable life skills so they could eventually be able to provide for themselves, and be morally rehabilitated (due to thinking disabilities are outward manifestations of corrupt souls). Over time, however, this educational facility that had originally provided nurturing care and solid foundations became a neglectful, abusive custodial institution. Eventually, due to inadequate funding, the incarcerated students who were not physically disabled were used as sources of manual labor to keep the institution functioning without hiring more employees. Years later, at a news conference, one past student at the institution stated, “Instead of being taught, we were being used, and I don’t think that was right. I don’t have the education that a lot of students have now because of my upbringing here. I wasn’t taught anything, I have trouble reading, I can’t spell, I try to get help, and I can’t get help” [5].

This created a perfect opportunity for exploitation of the students.

Because of the large numbers of easily obtainable subjects, MIT recruited disabled students from the Fernald School for an exclusive “science club” at the university. The students were enticed to participate through bribery. Science Club members were offered special privileges including beach trips, better dinners, and access to sporting events. In return for these privileges, the students would be required to participate in various scientific studies, such as the Quaker Oats nutrient tracer study [1,5].

In total, the MIT tracer study used 40 students, ages 7 to 17, to conduct three tracer experiments with the goal of understanding how the body absorbs minerals. The first experiment involved a few dozen students who were fed Quaker Oats cereal coated with small amounts of radioactive iron [1,12]. The radioactive iron chemically behaves just as natural iron would in the body, but its radioactive nature allows it to be traced. In order to trace the iron, the scientists collected frequent blood, urine, and/or stool sample from the participants, measuring the radioactive emissions using a special detector [1,7]. This study revealed that the absorption rate of iron from rolled oats was no less than farina (Cream of Wheat) [1]. The second experiment involved 36 students who received two breakfasts each [1,2]. The milk given to them was spiked with a radioactive calcium tracer, similar to that of the iron, to understand if the phthalate compounds in the oats interfered with dietary uptake of calcium from the milk. The calcium tracer study showed that absorption of a sufficient amount of calcium would not be significantly affected by the phthalates in the oats. The final experiment involved nine students who had radioactive calcium injected directly into their bloodstream to serve as a baseline for how calcium is absorbed in the body without any interference from food or digestion [2].

“Instead of being taught, we were being used, and I don’t think that was right”

The research done by MIT for this study was very well controlled, researched, and executed from a scientific rigor standpoint [1,2]. Therefore, the studies are still considered major scientific discoveries. However, serious ethical issues underlie these ground-breaking studies [5,7]. Due to the state of the Fernald School, operating as a corrupt, underfunded, and apathetic institution, the boys living there were easy targets, vulnerable to coercion with food and fun and ill-equipped to question the studies that would be done at MIT. The parents were not informed either, and were not in a position to intervene. Most of the boys participating in the study were wards of the state2 , therefore the state, not the parents, were their legal guardians. In addition to this, informed consent laws to protect human research subjects did not exist at this time, especially for disabled individuals [7,10]. Consequently, informed consent was not provided to the participants or any living parents. The superintendent of the Fernald School was able to make medical decisions on behalf of the students [5].

Nevertheless, the school did provide parents with two very deceptive letters, which briefly explained what their child would be participating in, but did not ask for approval. These letters did not give any details of the study, did not mention experiments with radioactivity, nor did they state the possible risks associated with their child’s participation [11]. These letters further alluded that consent from the parent was accepted unless otherwise stated, in an effort to protect the school from any accusations of wrong-doing. Although unethical,these experiments were perfectly legal at that time, due to the lack of modern-day ethical and medical guidelines 3 [7,10]. Interestingly, the researchers conducting this study claimed that disabled children consumed larger amounts of cereal than the average juvenile, to justify their choice to use the boys from Fernald [1,11].

First letter written to inform parents of MIT tracer study – 1949

“Some of us had to sign our own forms, but at that particular time I could not read or write. I had no knowledge of anything other than the fact that I do what I’m told when I’m told.”

– Austin LaRoque, Fernald State School Student

In 1993, almost 40 years after the conclusion of the tracer studies, MIT employed a task force to follow up on the research participants and determine if there were any lasting effects [3]. During the time of participation, the boys involved in the studies experienced levels of radiation equivalent to 50 chest x-rays [3,8]. Luckily, no severe effects were found. It is now known that the amount of radiation the boys experienced was less than current legal regulations. While participants didn’t experience any health complications, their safety had been jeopardized without their knowledge or their parents’. Therefore, the MIT task force suggested, “…all participants who were involved in human subject research which used radioactive materials at Massachusetts-operated facilities for persons with mental retardation should be compensated for any and all damage incurred as a result of such research” [4,9].

Radiation exposure levels in comparison to Tracer Study radiation exposure

MIT chose not to act upon the task force’s suggestion until 1997, when a class action lawsuit for $60 million was filed against MIT and Quaker Oats by study participants and their families, arguing it was a violation of their civil rights. Both MIT and Quaker Oats agreed on a settlement of $1.85 million to each participant to “avoid the expense and diversion of a lengthy legal battle” [4,9]. In addition, MIT’s research director, Dr. Bertran Brill stated, “I admit they shouldn’t have focused on a population that was so captive and had no alternative. That was wrong” [9]. With this statement, the students at Fernald State School were finally indemnified for what had been done to them as children.

Unfortunately, this is not the only time vulnerable groups were targeted for scientific experimentation. From disabled boys, to prisoners, to minority and economically troubled groups, targeting powerless individuals is a shameful trend in the history of science. Even if the studies themselves are scientifically sound, acknowledging the unethical decisions surrounding these studies is very important . Respecting the human rights of all individuals is far more important than any scientific discovery. It is essential that we learn from our past, so that the next generation of scientists will never allow exploitation such as this to happen again.

  1. DISCLAIMER | This study in no way reflects the current ethical decisions of Massachusetts Institute of Technology, Quaker Oats, or any associated studies. ↩︎
  2. A juvenile or incapacitated adult placed under the care of the government due to orphancy, abandonment, or inability to care for the child or for oneself ↩︎
  3. 1947 – Nuremberg Code introduced the ides of voluntary informed consent (not U.S. law, but influenced enactment)
    1964/1975 – Declaration of Helsinki created to serve as the international ethics code for medical research, requiring informed consent, independent review, and protection of vulnerable groups (not binding U.S. law but heavily shaped it)
    1974 – National Research Act was passed in the U.S. and served to require Institutional Review Boards (IRBs) ethics committees and protect people in federally funded research
    1979 – Belmont Report passed as a foundational ethics document explaining respect for persons/informed consent, beneficence to minimize harm, and justice to ensure fair subject selection, explaining why the laws should exist
    1991/2018 Revision – Common Rule for Federal Policy for Human Subjects Protection is the core rule that requires informed consent with full explanation of risk, IRB approval, and gives further protection to children, prisoners, pregnant persons, and people with impaired-decision making, allowing for the monitoring of ongoing studies and ability to withdraw at any time ↩︎

REFERENCES

1 | Boissoneault, L. (2017, March 8). A Spoonful of Sugar Helps the Radioactive Oatmeal Go Down. Smithsonian Magazine. https://www.smithsonianmag.com/history/spoonful-sugar-helps-radioactive-oatmeal-go-down-180962424/

2 | Bronner, F., Harris, R. S., Maletskos, C.J., & Benda, C. E. (1956). Studies in Calcium Metabolism; the Fate of Intravenously Injected Radiocalcium in Human Beings. The Journal of Clinical Investigation, 35(1), 78–88. https://doi.org/10.1172/JCI103254

3 | Campbell, K. D. (1994, May 11). Task Force Finds Fernald Research had no Significant Health Effects. MIT News | Massachusetts Institute of Technology. https://news.mit.edu/1994/fernald-0511

4 | Court Approves Fernald Settlement. MIT News | Massachusetts Institute of Technology. (1998, January 7). https://news.mit.edu/1998/fernald-0107

5 | Crockett, Z. (2022, March 20). The Dark Secret of the MIT Science Club for Children. Priceonomics. https://priceonomics.com/the-mit-science-club-for-disabled-children/

6 | Daly, M. E. (n.d.). History of the Walter E. Fernald Development Center. https://www.city.waltham.ma.us/sites/g/files/vyhlif12301/f/file/file/fernald_center_history.pdf

7 | Denny, S. (n.d.). Advisory Committee on Human Radiation Experiments Final Report. US Department Of Energy. https://ehss.energy.gov/ohre/roadmap/achre/chap7_5.html

8 | McCandless, D., & Hancock, M. (2013, August). Radiation Dosage Chart. Information is Beautiful. https://informationisbeautiful.net/visualizations/radiation-dosage-chart/

9 | MIT Announces Settlement of Fernald Nutrition Studies Suit. MIT News | Massachusetts Institute of Technology. (1997, December 30). https://news.mit.edu/1997/fernald

10 | Office for Human Research Protections (OHRP). (2026, January 15). Federal policy for the Protection of Human Subjects ‘Common Rule. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html?utm_source=chatgpt.com

11 | Sharav, V. (2016, April 20). MIT reviews Fernald nutrition studies; Vest expresses concern. MIT News | Massachusetts Institute of Technology. https://ahrp.org/1944-1956-radioactive-nutrition-experiments-conducted-by-harvard-and-mit-on-disabled-children/?utm_source=chatgpt.com

12 | West, D. (1998, January). Radiation experiments on children at the Fernald and wrentham schools: Lessons for protocols in human subject research. Accountability in research. https://pubmed.ncbi.nlm.nih.gov/11660586/

IMAGE REFERENCES

1 | Digital Collections – University at Buffalo Libraries. (1901). Advertisement for Quaker oats [Photograph]. Public Domain. Retrieved from https://digital.lib.buffalo.edu/items/show/95016

2 | Fernald State School and Hospital. (Date Unknown). North Building — Historic images and photo gallery. Public Domain. Retrieved from https://fernaldstateschool.com/buildings/north

3 | Human Eugenics Records Archive. (1922). Photograph of Fernald boys in nutrition experiments. Public Domain. Retrieved from http://www.eugenicsarchive.org/html/eugenics/static/images/864.html

4 | Crockett, Z. (1949, 2016). The Dark Secret of the MIT Science Club for Disabled Children [Letter reproduced]. Priceonomics. Public Domain. Retrieved from https://priceonomics.com/the-mit-science-club-for-disabled-children/

5 | Self-Produced. (2026). Information Retrieved from https://informationisbeautiful.net/visualizations/radiation-dosage-chart/

Beyond the Clock

amossinLeave a comment

By Anna Mossing

A Sign From God. Illustration generated by DALL-E 3 prompted by S. Perquin. Wikimedia Commons. https://commons.wikimedia.org/wiki/File:A_sign_from_God.png

Isolation stems from a feeling of disconnect, where a physical or emotional distance is often observed. Yet, what about a rhythmic separation?

How do you feel when daylight savings occurs? Or when you deplane from a cross-country red-eye flight? The human body is governed by a circadian rhythm. When your internal clock is skewed due to time changes, you will typically feel disconnected from the rest of the world. A simple solution to calibrate your circadian rhythm is exposure to sunlight. For example, if sunlight isn’t available during a dark Alaskan winter, alternative technologies like light boxes can deliver light at approximately the same wavelengths as sunlight. What if someone is blind and has a complete lack of light detection in their eyes? Neither sunlight nor alternative light therapies would re-set their circadian clock. 80% of blind individuals report sleep disturbance, and over half of totally blind individuals experience a condition called Non-24-Hour Sleep-Wake Disorder, aka “Non-24.”1 This sleep disorder causes a chronic separation from a regular 24-hour circadian rhythm, and isolates the individual from friends, family, and society.1

Allen, A. E. (2019). Circadian rhythms in the blind. Current opinion in behavioral sciences, 30, 73-79.

A circadian rhythm is naturally aligned with the Earth’s 24-hour cycle of day and night. The primary cue for synchronizing this rhythm is light, especially sunlight.3 When light hits the retina, it sends signals to the suprachiasmatic nucleus in the brain, which is the master regulator of the circadian rhythm.3 When there is no ocular light detection, no signal is sent and the body cannot synchronize with the day/night schedule.

In 1977, a 28 year-old blind post-graduate student, J.X., struggled to maintain a typical schedule in alignment with his academic and leisure activities.2 Frustrated, and looking for a solution, he set regulated meal and bedtime routines, took stimulant medications, and kept a sleep journal.2 The sleep journal seemed to suggest that he was set on a circadian rhythm longer than 24 hours. To find a solution to this imbalance, Miles entered a medical study. He was encouraged to eat, work, and sleep intuitively, and his alertness, performance, temperature, pulse, and respiration were continuously monitored over a period of 26 days.2

Miles was diagnosed with Non-24 and a 24.9-hour sleep-wake cycle.2 By living according to his own intuitive schedule during the study, Miles did not suffer from excessive tiredness during the day or insomnia at night.2 He felt normal for the for the first time in years. However, his intuitive schedule puts him at odds with the rest of the world.

The second part of the study was specified as an entrainment attempt.2 Miles was scheduled for regimented times of eating, working, and sleeping based on a 24-hour circadian rhythm.2 As weeks progressed with these constraints, he became increasingly restless at night and observably exhausted during the day. Throughout both parts of the sleep study, Miles’ cortisol levels were measured.2 When his cortisol levels were compared to a typical 24-hour circadian rhythm, they seemed sporadic. However, his cortisol levels were a perfect match to a 24.9-hour cycle.2

The best solution for Miles’ well-being was to stick to a 24.9-hour cycle, but his circadian rhythm wasn’t in line with the rest of the world. This created a “scheduling” dilemma for Miles. He had to choose between his own health, and his career advancements and relationships. Navigating this dilemma would impact Miles’ overall quality of life, as he had to choose between quality opportunities and quality health.

Since Non-24 affects a range of people with different backgrounds, ages, and lifestyles, people use a range of methods to manage this disorder and combat its effects. Some use schedule regulation as their primary mode of management, while others use medication.2 Miles coped with his Non 24 through a technique called “free running,” in which he allowed his body to maintain a 24.9-hour cycle.2 While this might decrease his career opportunities and cause tension in friendships, he chose to protect his physical well-being.

(a) Typical sleep-wake schedule. (b) Free running sleep-wake schedule. Allen, A. E. (2019). Circadian rhythms in the blind. Current opinion in behavioral sciences, 30, 73-79.

Mindy, a 60 year-old woman, was born with impaired vision and lost all ocular light detection by the age of 10.8 Once she completely lost light detection, she began struggling with maintaining a regular sleep schedule.8 Eventually she had to stop working due to chronic exhaustion.8 Before being diagnosed with Non-24, Mindy felt hopeless and out of touch with her body.8 Despite being interested in and excited for different events, she missed concerts, lectures, and social gatherings due to her exhaustion or suffered anxiety about falling asleep at events.8 When Mindy was finally diagnosed with Non-24, she experienced hope after years of disappointment. “When I finally got the diagnosis, I couldn’t have been happier. I felt lighter. I felt as though tons of bricks had been lifted off my shoulders, and I felt free. I came home from the doctor feeling like someone had finally heard me,” said Mindy.8 Knowing she has Non-24, Mindy now feels more aware of her body, explaining a new sense of control, “If I am aware then I can plan accordingly.”8

“When I finally got the diagnosis, I couldn’t have been happier… I came home from the doctor feeling like someone had finally heard me.”

As diagnoses of Non-24 became more common, one pharmaceutical company started researching treatments. Between 2010 and 2012, Vanda Pharmaceuticals developed Hetlioz (Tasimelteon) to treat Non-24.4 However, the drug was controversial in practice. During the development of Hetlioz, volunteers dropped out of several clinical trials.4 The drug had a modest success rate, only 29% improvement as compared to 13% in the placebo group.4 Many people have had mixed feelings and experiences with this drug, with some commenting on WebMD reviews. One of these commenters, Ted, was part of a clinical trial for Hetlioz.5 While on the medication, Ted struggled for several nights with nightmares and sleep paralysis, and he also developed urinary tract infections.5 When Ted contacted Vanda Pharmaceuticals about these side effects, he felt they were evasive with their answers and not empathetic.5 Ianto, another reviewer, was prescribed Hetlioz by his doctor.5 Like Ted, Ianto also faced disturbing and vivid dreams.5 He reported that while on Hetlioz, “I slept 12 hours – but it was not good sleep. I sleep 8 hours normally. I simply could not get out of bed, even after waking up at 6, 8, and 10 hours. I was beyond exhausted.”5 In both of these cases, taking Hetlioz amplified the burdens of Non-24 instead of alleviating them. Although Hetlioz was initially approved in 2014, the drug was recently recalled in early 2024 on the grounds of mislabeling, a lack of evidence for long-term efficacy, and the lack of subjective patient reported data in the clinical studies.7

Amid this backlash, other patients on WebMD reviews have reported life-changing effects with Hetlioz. Metalones, a 40 year-old mother, experienced both personal and social benefits after beginning Hetlioz, explaining “I was finally able to experience what it was like to be ‘normal’ and not be looked down on for being ‘irresponsible or lazy’.”5 She began homeschooling her daughter and making appointments earlier in the day to take care of herself and family, something she wasn’t able to do before, due to excessive exhaustion.5 When Hetlioz was recalled, Metalones’ insurance no longer covered the cost.5 With an out-of-pocket cost of approximately $19,000 per month, or $228,000 a year,6 Metalones couldn’t afford to pay for Hetlioz herself, so she had to stop taking it.5 Without Hetlioz, Metalones reported regression in her mental well-being, stating, “I’ve spiraled back down into severe depression and anxiety and stay in bed most of the day, because I’m too exhausted and apathetic to get up and do anything. I’m a shell of the person I used to be.”5

The misalignment of the external world with one’s internal rhythm in people with Non-24 introduces and reinforces an intense disconnect that must be bridged. Personalized approaches to manage Non-24, like free running and adjusted schedules, promise hope to some patients. However, successful deployment of these strategies depend greatly on the understanding and support of family and colleagues. Hetlioz has the potential to help, yet its benefits are diminished by the negative side effects, high cost, and lack of access. There are currently no other drugs approved for the treatment of Non-24, so more accessible treatments and improved technologies need to be developed in order to find an effective and sustainable solution. Management of Non-24 should not fall on the shoulders of patients alone. We all have a responsibility to develop a greater awareness of and accommodate those struggling with Non-24, so that this chronic separation from day and night does not cause a chronic separation from the world.

References

  1. Non-24-Hour Sleep-Wake Disorder. National Organization for Rare Disorders. (2023, November 20). https://rarediseases.org/rare-diseases/non-24-hour-sleep-wake-disorder/
  2. L. E. M. Miles et al., Blind Man Living in Normal Society Has Circadian Rhythms of 24.9 Hours. Science 198, 421-423 (1977). DOI:10.1126/science.910139
  3. Şahin, Z., Kalkan, Ö. F., & Aktas, O. (2022). How Does the Circadian Rhythm Function in Blind People Who Have No Light Perception?. Hipokrat Tıp Dergisi, 2(2), 38-46.
  4. Lockley, S. W., Dressman, M. A., Licamele, L., Xiao, C., Fisher, D. M., Flynn-Evans, E. E., … & Polymeropoulos, M. H. (2015). Tasimelteon for non-24-hour sleep–wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials. The Lancet, 386(10005), 1754-1764.
  5. WebMD. (n.d.). Hetlioz oral reviews and user ratings: Effectiveness, ease of use, and satisfaction. WebMD. https://reviews.webmd.com/drugs/drugreview-165884-hetlioz-oral
  6. Tasimelteon Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com. https://www.drugs.com/price-guide/tasimelteon
  7. The Food and Drug Administration. (2024, June 7). Federal Register :: Proposal to refuse to approve a new drug application supplement for hetlioz (tasimelteon); opportunity for a hearing. Federal Register. https://www.federalregister.gov/documents/2024/06/07/2024-12564/proposal-to-refuse-to-approve-a-new-drug-application-supplement-for-hetlioz-tasimelteon-opportunity
  8. Non-24-Hour Sleep-Wake Disorder. (2012, June 7). Living With Circadian Sleep Condition: Non-24-Hour Disorder. YouTube. https://www.youtube.com/watch?v=CqBaY8577cQ