Sterol Biosynthesis–Inhibiting Medications (SBIMs)

  In The Politics of Autism, I discuss various ideas about what causes the condition.  Dozens of potential causes and correlates have been the subject of scientific and medical research.

A release from the University of Nebraska Medical Center:

A landmark study led by researchers at the University of Nebraska Medical Center (UNMC) and published in Molecular Psychiatry has identified a significant association between prenatal prescription of commonly utilized medications and the risk of autism spectrum disorder (ASD) in children.

Analyzing 6.14 million maternal-child health records from the Epic Cosmos database—representing nearly one-third of all U.S. births between 2014 and 2023—the team found that prescription of medications known to inhibit the cholesterol synthesis pathway were consistently associated with higher rates of ASD in offspring.

While previous studies grouped medications by their indications, the UNMC team grouped prescribed medications together based on common effects and side effects on sterol biosynthesis.

These sterol biosynthesis–inhibiting medications (SBIMs) include certain antidepressants, antipsychotics, anxiolytics, beta-blockers and statins. These are the generic names of the 14 medications studied: aripiprazole, atorvastatin, bupropion, buspirone, fluoxetine, haloperidol, metoprolol, nebivolol, pravastatin, propranolol, rosuvastatin, sertraline, simvastatin and trazodone. Many of these are among the most commonly prescribed medications in the United States, accounting for more than 400 million annual prescriptions.

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Publication details

Eric S. Peeples et al, Sterol pathway disruption in pregnancy: a link to autism, Molecular Psychiatry (2026). DOI: 10.1038/s41380-026-03610-7 Journal information: Molecular Psychiatry

A partial list of other potential causes and correlates: 

1. Inflammatory bowel disease
2. Pesticides
3. Air pollution and proximity to freeways
4. Maternal thyroid issues
5. Autoimmune disorders
6. Induced labor
7. Preterm birth
8. Fever  
9. Birth by cesarean section;
10. Anesthesia during cesarean sections
11. Maternal and paternal obesity
12. Maternal diabetes
13. Maternal and paternal age
14. Grandparental age
15. Maternal post-traumatic stress disorder
16. Maternal anorexia
17. Smoking during pregnancy
18. Cannabis use during pregnancy
19. Antidepressant use during pregnancy
20. Polycystic ovary syndrome
21. Infant opioid withdrawal
22. Zinc deficiency
23. Sulfate deficiency
24. Processed foods
25. Maternal occupational exposure to solvents
26. Congenital heart disease
27. Insufficient placental allopregnanolone
28. Estrogen in the womb
29. Morning sickness;
30. Paternal family history
31. Parental preterm birth
32. Antiseizure meds
33. Location of forebears
34. Lithium
35. Aspartame
36. BPA
37. Brain inflammation
38. Maternal asthma
39. Infertility
40. Ultraprocessed foods
41. Household chemicals
42. Parental psychiatric disorders
43. Fluoride
44. Fatty acids in umbilical cord blood
45. Maternal inflammation during pregnancy
46. COVID-19
47. Wildfire smoke

 

The Autism Drug Market

In The Politics of Autism, I discuss treatments, including medication.

There are currently no medications for the core symptoms of autism.  But many autistic people do take drugs for irritability, anxiety, depression, and other co-occurring conditions.

A release from Fortune Business Insights:

According to a report published by Fortune Business Insights, titled, “Autism Spectrum Disorder Therapeutics Market”: Global Market Analysis, Insights and Forecast, 2018-2026,” the global market is likely to reach US$ 4,612.1 Mn by 2026 owing to the rising incidence of autism spectrum disorder worldwide. The report provides valuable insights into the global market trends and factors that are directly affecting the growth of the market. As per the report, the global autism spectrum disorder therapeutics market was worth US$ 3,293.0 Mn in 2018. Considering the increasing awareness programs regarding this particular disorder and less availability of treatment options, the global market is expected to rise at a moderate CAGR of 4.3% during the forecast period (2019-2026).

Key Players Operating in The Autism Spectrum Disorder Therapeutics Market Include:
Key players are involved in mergers and acquisition to strengthen their market position. Owing to increasing competition frequent innovations are taking place in the market. Some of the companies operating the industry are:

• Applied Behavior Consultants,
• Allergan,
• Pfizer Inc.,
• Q BioMed Inc,
• Fusion Autism Center,
• AstraZeneca,
• Hopebridge, LLC.,
• Johnson and Johnson Services, Inc.,
• Behavior Innovations,
• Eli Lilly and Company,
• Otsuka Holdings Co. Ltd.,
• other prominent market players.

Request a Sample Copy of the Research Report:https://www.fortunebusinessinsights.com/enquiry/request-sample-pdf/autism-spectrum-disorder-therapeutics-market-101207

Testing Balovaptan

In The Politics of Autism, I discuss treatments, including medication.

At City News in Toronto, Faiza Amin reports:

Drug manufacturer Hoffmann-La Roche has commissioned an international research study for Balovaptan, a drug that could potentially help people on the spectrum manage everyday social and communication challenges better.

“It’s regulating hormones in our brain that have to do with how we perceive the social world, whether we understand social cues, how we relate to other people, and how we develop close bonds and relationships,” said Dr. Evdokia Anagnostou, the study’s lead researcher at Toronto’s Holland-Bloorview Kids Rehabilitation Hospital.
...
The Autism community remains divided on the drug, as one disability rights group in Ontario has raised concerns around whether or not the pill is ethical.

Autistics 4 Autistics Ontario (A4A) is a self-advocacy group for adults with autism, calling for reform to autism funding and services at the federal and provincial levels. Anne Borden, a member of the province’s A4A executive board, tells CityNews the organization opposes the drug and the research, saying it could prey upon people’s hopes and dreams.

“Who is this benefiting?” Borden asks. “This kind of research represents a very old way of approaching autism, looking at autistic people like they’re a problem to be solved or sort of a broken version of normal, rather than taking a position of acceptance.”

Borden said developing a pill for this purpose speaks to the dignity of people with autism, and can negatively affect how they are treated and perceived. She called this a “profit-generating” pill that may put “people from a vulnerable population” at risk, adding that there are ethical questions rooted in its very existence.

“There’s a deep psychological impact when all the people in your life are constantly trying to fix you for who you are and, in this case, gives you a pill to make you act differently,” Borden said.

“It’s not looking at communication as a two-way street. Whereas other ideas like inclusion, accessibility, communication, dialogue, and research into the access needs of autistic people will do that.”

Autistic Adults Get a Lot of Psychotropic Meds

In The Politics of Autism, I discuss treatments, including medication.

At The Journal of Autism and Developmental Disorders, Amy Esler and colleagues have an article titled "Psychotropic Medication Use for Adults with Autism Spectrum Disorder who Receive Services and Supports Through Adult Developmental Disability Services in the United States."  The abstract:

Individuals with autism spectrum disorder (ASD) have higher rates of co-occurring diagnoses and use of psychotropic medication prescriptions than people with other developmental disabilities. Few studies have examined these trends in samples of people with intellectual and developmental disabilities (IDD) with and without ASD. Using a random sample of 11,947 adult IDD service users from 25 states, co-occurring diagnoses and psychotropic medication use were compared for those with and without ASD. Regardless of diagnosis, individuals with ASD had higher percentages of psychotropic medication use. Controlling for co-occurring condition, age, gender, and ID level, a diagnosis of ASD predicted number of medications used. Further research is needed to understand why individuals with ASD are prescribed more medication, more often, than similarly functioning groups of individuals without ASD.

Autism Hype

In The Politics of Autism, I discuss various ideas about what causes the condition and how to treat it.  I also write:  "If the science were not confusing enough, its coverage in the mass media has added another layer of murk.  News reports hype tentative findings and weak correlations as “breakthroughs” in the quest for autism answers. 

At Scientific American, Alycia Halladay writes:

In the worst scenarios, families inspired by media coverage may pursue treatments that are both ineffective and unsafe. This has been the case with MDMA, or 3,4-methyldioxymethamphetamine, otherwise known as ecstasy, to treat social anxiety in autistic adults. Much media coverage of this experimental treatment failed to report that the drug is neurotoxic in animal models and humans, and that a “safe” dose has not been established. As a result, the public received complete misinformation via mainstream media outlets. The false hope of MDMA might have led some in the autism community to pursue an illegal—and, more importantly, potentially lethal—intervention.
...
. In another case, the headline “Stem Cells Offer Hope for Autism” might have encouraged families to travel to international sites with unregulated medical practices to obtain this therapy, which is still unproven. Conversely, the media is largely missing the mark on the potential of medical marijuana, confusing different cannabinoids and mixing up indications in their headlines. This type of misinformation will only serve to stifle badly needed research into phytocannabinoids in marijuana that do, in fact, show promise for treating epilepsy, which commonly co-occurs in children with autism.

Opioid Withdrawal and Autism

In The Politics of Autism, I discuss various ideas about what causes the condition. Here is just a partial list of correlates, risk factors, and possible causes that have been the subject of serious studies:

• Pesticides;
• Air pollution and proximity to freeways;
• Maternal thyroid issues;
• Autoimmune disorders;
• Induced labor;
• Preterm birth;
• Fever  
• Birth by cesarean section;
• Maternal and paternal obesity;
• Maternal diabetes;
• Maternal and paternal age;
• Maternal post-traumatic stress disorder;
• Smoking during pregnancy;
• Antidepressant use during pregnancy;
• Polycystic ovary syndrome.

Christina Samuels at Education Week:

Researchers examined the educational status of a group of Medicaid-eligible children in Tennessee ages 3 to 8. Some of those children were born with neonatal abstinence syndrome, meaning that they spent their earliest days coping with the health effects of opioid withdrawal. The other children were not diagnosed with the syndrome.

The children who faced opioid withdrawal as babies were more likely to be evaluated for special education services and, once evaluated, were more likely to be found eligible, according to the report, published in August in the journal Pediatrics. Most of the children's disabilities were in five categories: autism, developmental delay, "other health impairment," specific learning disability, and speech and language impairments

Antipsychotic Drugs

In The Politics of Autism, I write about medical and scientific research.

A release from Elsevier:

About one in ten youths treated with an antipsychotic are diagnosed with autism spectrum disorder or intellectual disability. Conversely, one in six youths diagnosed with autism spectrum disorder has been prescribed antipsychotics. These findings are reported in the June 2016 issue of the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). Furthermore, the results suggest that the proportion of adolescents with autism or intellectual disability has increased among youths treated with antipsychotics and that more youths with autism or intellectual disability have received antipsychotics.

Currently, second-generation antipsychotics are the only FDA-approved medications for youth with autism. However, these are approved only for the symptomatic control of irritability and aggression. They do not have an indication for youth with intellectual disability, and they do not seem to affect the core symptoms of autism spectrum disorders, such as social and communication difficulties, or the core symptoms of intellectual disability, such as problems with understanding and responding appropriately to information from the outside world.

Performing a meta-analysis of 39 studies and over 350,000 youth with mental illness, a group of researchers led by Christoph U. Correll, MD, of Hofstra Northwell School of Medicine, examined the frequency and time trends of antipsychotic prescribing in youth with autism spectrum disorders or intellectual disability, mostly drawing on data from large registry-based studies.

“Although the increased prescribing of antipsychotics in youth with autism spectrum disorders or intellectual disability cannot be judged as appropriate or inappropriate based on database studies, side effects of antipsychotics can be quite problematic, especially in children and adolescents,” said Correll. “Therefore, clinicians should perform very careful risk: benefit evaluation before and after starting youth with autism spectrum disorders or intellectual disability on an antipsychotic, always trying to maximize non-pharmacologic interventions as well as pharmacologic or non-pharmacologic treatments for comorbidities, including attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, and sleep disorders.”

Based on the study results and the known adverse effects of antipsychotics, the authors concluded that clinicians should consider using psychosocial interventions that are proven to be efficient for behavioral dysregulation such as irritability and aggression, before prescribing antipsychotics to adolescents with autism or intellectual disability. The authors further stressed that when prescribing antipsychotics, it is imperative to regularly monitor both their efficacy and tolerability in patients through body weight, fasting lipids and glucose, extrapyramidal side effects, sedation, and sexual/reproductive adverse effects, and to manage abnormalities appropriately.
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Notes for editors
The article is “Antipsychotic Use Trends in Youth With Autism Spectrum Disorder and/or Intellectual Disability: A Meta-Analysis” by Su Young Park, Chiara Cervesi, Britta Galling, Silvia Molteni, Frozan Walyzada, Stephanie H. Ameis, Tobias Gerhard, Mark Olfson, and Christoph U. Correll (doi: 10.1016/j.jaac.2016.03.012). It appears in the Journal of the American Academy of Child and Adolescent Psychiatry, Volume 55, Issue 6 (June 2016), published by Elsevier.

Pushback on the Antidepressant Article

In The Politics of Autism, I discuss various ideas about what causes the condition.  An earlier post discussed a new study that raises a possible link to antidepressants.  The post also includes skeptical commentary, which is mounting.

Alison Stuebe writes at The Huffington Post:

Importantly, the study defined "autism" as a medical service claim or hospital code for autism or several related diagnoses. When the authors looked only at cases of autism that were confirmed by psychiatrists, link with antidepressants was no longer statistically significant. That means the study found that taking medications for depression is linked with having a child evaluated for autism, but not with actually having autism.

But that's not the fundamental limitation of study. The key problem is that women who take a medication when they are pregnant have a reason for taking it. Blaming the outcome on the medication, without considering the underlying disease, is like saying that umbrellas cause flooding. Taking away the umbrellas -- "not treating the rain" -- does not prevent flooding; it just means that people get soaked.

Furthermore, the authors did not compare women taking antidepressants with women with similarly severe depression who stopped their medication. ... The authors tried to sort this out by comparing women with a history of depression with women who were taking antidepressants. However, these two groups are very different. A woman with a "history of depression" might have been depressed in high school when her grandparent died, and then been fine thereafter. She is completely different from a woman who is continuing to take antidepressants during pregnancy because she has severe major depressive disorder and a history of a suicide attempt.

In  The Politics of Autism, I write: :If the science were not confusing enough, its coverage in the mass media has added another layer of murk. News reports hype tentative findings and weak correlations as `breakthroughs' in the quest for autism answers."

David Auerbach writes at Slate:

Study co-author Bérard, it turns out, has been criticized by a federal judge for cherry-picking results to link antidepressants to birth defects. The press should treat such studies with skepticism rather than leading with their findings. Sober pieces inScience, Wired, and NPR rightly questioned whether the study was significant and whether Bérard’s advocacy for stopping antidepressant usage during pregnancy was justified. In particular, Emily Underwood in Science wisely led off by writing “Many epidemiologists and psychiatrists say the study, published today in JAMA Pediatrics, is flawed and will cause unnecessary panic,” which is the most important point to make about this study. But too many journalists failed to make this point, and with autism research, such credulity is downright dangerous.

H

Risperdal

Though there is no drug for the core symptoms of autism, most ASD kids are on meds.  There is widespread concern both about overmedication and use of the wrong medications.

A Monday release from the US Justice Department reports on legal action concerning Johnson and Johnson, as well as Janssen Pharmaceuticals Inc., a J&J subsidiary.

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
...
In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.
...

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

Petition Against Over-Medication in New York

A recent post described over-medication in New York State institutions for the developmentally disabled.  The Autistic Self-Advocacy Network has an online petition against the practice.  From the petition:

A recent New York Times expose documented the extensive overmedication of people with disabilities in residential service-provision. According to the Times, people with developmental disabilities in group homes in New York are more likely to be given Ativan, an anti-anxiety drug that also serves as a tranquilizer, than multivitamins. In many cases, psychotropic medication is prescribed as a chemical restraint to control behavior, even when it lacks any therapeutic purpose. Data from the National Core Indicators project, a national database run by the Human Services Research Institute and the National Association of State Directors of Developmental Disability Services, shows that the percentage of people with developmental disabilities receiving psychotropic medications is much higher than the percentage who have the co-occurring mental health conditions that might justify their use. This is a critical issue, and it is imperative that New York's Office for People with Developmental Disabilities and State Legislature take action to address it.

Over-Medication in New York

Danny Hakim of The New York Times continues to report on New York State's residential institutions for the developmentally disabled.  His latest report focuses on the use of psychotropic drugs.

Psychologists who have worked inside the system describe a culture in which the drugs are used to control the disruptive behavior of the developmentally disabled — people with conditions like autism, Down syndrome and cerebral palsy — an approach increasingly discredited in the field. ...

The drugs can have serious consequences. Risperdal, the second most frequently prescribed, was developed to treat psychotic disorders and has been approved for controlling aggression among people with autism. But its side effects can be extreme, including breast growth in adolescent boys, which in a small number of cases require mastectomies.

And even the use of the drugs to control behavior is questionable. A 2008 study published in the medical journal The Lancet found that psychotropic drugs like Risperdal were less effective at treating behavioral outbursts than placebos.

Dr. Roy Q. Sanders, who is the medical director of the Marcus Autism Center in Atlanta and has worked in New York, said, “I tell people all the time that the medications are really blunt tools when it comes to making substantial differences in behavior in developmentally disabled individuals.”

The Godboldo Case

WXYZ in Detroit reports:

A mother who is accused of firing at police as they tried to take her 13-year-old daughter into custody faced a judge on Sunday.

57-year-old Maryanne Godboldo appeared in 36th District Court via video link. Godboldo’s attorney asked the judge to let her go on personal bond, but the judge refused, saying the charges were too serious.

He set bond at $500,000.

Godboldo is accused of firing shots at police through the wall of her home. It happened after child protective services first went to her house on Blaine Thursday evening to take custody of her 13-year-old daughter.

Authorities say Godboldo was to lose custody because she was not properly treating her daughter’s mental illness. When she refused to answer the door for protective services, police were called, shots were fired and the stand-off ensued.

In court Godboldo’s attorney said the mother was not administering the drug because she believes in holistic approach to her daughter’s condition.

The attorney described the illness to the judge as “possible autism.” She said the daughter had been prescribed medication called Risperdal. The drug is used to treat a number of conditions, including schizophrenia, mania and depression.

The 13-year-old is being treated at a local mental facility. Relatives are hoping to ultimately get custody of her.