{"id":108165,"date":"2026-07-31T19:58:33","date_gmt":"2026-07-31T19:58:33","guid":{"rendered":"https:\/\/youzum.net\/montanas-new-right-to-try-law-cant-come-soon-enough-for-some\/"},"modified":"2026-07-31T19:58:33","modified_gmt":"2026-07-31T19:58:33","slug":"montanas-new-right-to-try-law-cant-come-soon-enough-for-some","status":"publish","type":"post","link":"https:\/\/youzum.net\/fr\/montanas-new-right-to-try-law-cant-come-soon-enough-for-some\/","title":{"rendered":"Montana\u2019s new \u201cright to try\u201d law can\u2019t come soon enough for some"},"content":{"rendered":"<div data-chronoton-summary=\"&lt;ul&gt;&lt;br&gt;&lt;li&gt;&lt;strong&gt;A father's race against time:&lt;\/strong&gt; Brody DeVault, 3, has creatine transporter deficiency, leaving his brain and muscles starved of energy. His dad fears that without treatment soon, Brody will miss a critical window for brain development\u2014possibly forever.&lt;\/li&gt;&lt;br&gt;&lt;li&gt;&lt;strong&gt;A promising drug just out of reach:&lt;\/strong&gt; A French biotech is developing a nasal spray that could help Brody, but it hasn't been FDA-registered, hasn't been tested in children, and its upcoming trial is in France\u2014likely too late and too far away.&lt;\/li&gt;&lt;br&gt;&lt;li&gt;&lt;strong&gt;Montana opens a door, but it's complicated:&lt;\/strong&gt; A new Montana law lets patients access unapproved drugs that have cleared early trials, but the French drugmaker fears FDA backlash\u2014and experts warn that early trials prove neither safety nor effectiveness.&lt;\/li&gt;&lt;br&gt;&lt;li&gt;&lt;strong&gt;Desperation drives the search for alternatives:&lt;\/strong&gt; With Montana's promise uncertain, Brody's father is eyeing an offshore clinic in Honduras\u2014a path many scientists warn against\u2014while arguing he should have the right to try anything that might help his son&lt;\/li&gt;&lt;\/ul&gt;\" data-chronoton-post-id=\"1140945\" data-chronoton-expand-collapse=\"1\" data-chronoton-analytics-enabled=\"1\"><\/div>\n<p>Kris DeVault is desperate.<\/p>\n<p>His son, Brody, was born in March 2023. It wasn\u2019t long before he started to show signs of developmental delay, says DeVault. As time went on, Brody started missing key milestones in speech, movement, and coordination, he says.<\/p>\n<p>When Brody was around two and a half years old, a genetic test revealed creatine transporter deficiency\u2014a rare condition in which the brain and muscles lack the energy they need to develop.<\/p>\n<p><strong>There are no cures for Brody\u2019s condition.<\/strong> But DeVault has learned of a company developing a drug that might help. That drug is still in the early stages of development and has only been tested in animals and a small number of healthy adults. Doctors can\u2019t prescribe it.<\/p>\n<p>DeVault knows the drug might not work. But he\u2019s doing all he can to access it regardless. And <a href=\"https:\/\/www.technologyreview.com\/2025\/05\/14\/1116428\/first-us-hub-for-experimental-medical-treatments\/?utm_source=the_checkup&amp;utm_medium=email&amp;utm_campaign=the_checkup.unpaid.engagement&amp;utm_content=07-30-26\" target=\"_blank\" rel=\"noreferrer noopener\">a new law in Montana<\/a> could make it easier for people in his position to get access to treatments\u2014at least in theory.<\/p>\n<p><strong>Today, Brody is three years old.<\/strong> His dad describes him as a happy, curious, and loving little boy who wants to learn. But Brody struggles to communicate. \u201cHe\u2019s got no words, really,\u201d says DeVault. \u201cHe wants to communicate more than he\u2019s able to \u2026 which then turns into frustration.\u201d<\/p>\n<p>It\u2019s difficult for Brody to tell his parents whether he\u2019s hot, cold, hungry, thirsty, uncomfortable, or even in pain, says DeVault. He recently found Brody standing on an anthill in the backyard, being bitten by red ants. \u201cThese fire ants were just going to town on his feet \u2026 and he was just looking,\u201d he says.<\/p>\n<p><strong>Brody has muscle weakness too.<\/strong> \u201cHe can\u2019t move very fast, he doesn\u2019t have a ton of strength \u2026 and it takes a lot of energy for him to walk balanced,\u201d says DeVault. \u201cHis arms are skinnier than [those of] his nine-month-old sister.\u201d<\/p>\n<p>It\u2019s concerning, but DeVault is most worried about Brody\u2019s neurological development. Toddlers\u2019 brains are exceptionally \u201cplastic\u201d\u2014the first years of a child\u2019s life are thought to be\u00a0<a href=\"https:\/\/www.aap.org\/en\/patient-care\/early-childhood\/early-childhood-health-and-development\/early-brain-development\/\">crucial for long-term brain development<\/a>.<\/p>\n<p>A biotechnology company in France is working on a drug to help people like Brody. Creatine usually provides brain cells with energy. People with creatine transporter deficiency (CTD) can\u2019t get creatine into the brain.<\/p>\n<p>The team at Ceres Brain Therapeutics is developing a treatment designed to bypass this issue and effectively deliver creatine directly to the brain. So far, the team has seen promising results in mice, says Ceres CEO Thomas Joudinaud.<\/p>\n<p>The company also recently completed a phase I clinical trial that involved testing various doses of the drug, which is delivered as a nasal spray, in 48 healthy adult volunteers. That trial has not yet been published, says Joudinaud. The drug has not been tested in people with CTD, or in children.<\/p>\n<p>\u201cI look at this, and I\u2019m like, that is my one shot for Brody,\u201d says DeVault.<\/p>\n<div class=\"wp-block-image\">\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1607\" height=\"1249\" src=\"https:\/\/wp.technologyreview.com\/wp-content\/uploads\/2026\/07\/family-inset.jpg?w=840\" alt=\"Brody Devault with his parents and baby sister\" class=\"wp-image-1140938\" \/><figcaption class=\"wp-element-caption\">Kris DeVault, his son Brody, and his wife and young daughter.<\/figcaption><div class=\"image-credit\">COURTESY OF THE DEVAULT FAMILY<\/div>\n<\/figure>\n<\/div>\n<p><strong>Joudinaud is planning a phase II trial in people with CTD,<\/strong> as well as others with amyotrophic lateral sclerosis. But that trial will take place in France, and it\u2019s unlikely that Brody will be able to take part, says DeVault.<\/p>\n<p>Ceres can\u2019t make the drug available to Brody under an expanded access scheme run by the US Food and Drug Administration either, because the drug has not been registered with the FDA, and because it is currently manufactured in a way that does not comply with FDA regulations, says Joudinaud.<\/p>\n<p>Even if that phase II trial is successful, and if the drug is ultimately approved, it is unlikely to reach the US market for at least a few years. DeVault is worried that will be too late for Brody\u2014he\u2019ll be \u201cpast his plasticity window\u201d by then, he says.<\/p>\n<p><strong>Now, with the adoption of a new law in Montana, he theoretically has another option. <\/strong>Montana has had a \u201cright to try\u201d law\u2014which allows terminally ill people to apply for access to unapproved drugs\u2014in place since 2015. In 2023, a new law technically expanded this option to people who were not terminally ill, providing the drugs have been through preliminary phase I clinical trials. A second law aimed to clarify how clinics could sell and administer those treatments to patients. And last weekend, the state\u2019s department of Health and Human Services <a href=\"https:\/\/www.technologyreview.com\/2026\/07\/30\/1140942\/montana-experimental-medical-hub-pushed-forward-right-to-try\/?utm_source=the_checkup&amp;utm_medium=email&amp;utm_campaign=the_checkup.unpaid.engagement&amp;utm_content=07-30-26\" target=\"_blank\" rel=\"noreferrer noopener\">finalized a set of rules for those clinics<\/a>.<\/p>\n<p>An experimental treatment review board (ETRB) has been established to review applications for access to experimental, unproven, and unapproved drugs. And it is set to review its first two applications in the coming weeks.<\/p>\n<p>Ceres could also apply to Montana\u2019s ETRB to sell its experimental treatment to Brody\u2019s parents via a clinic in the state. But Joudinaud is reluctant, at least for the time being. While he thinks that Montana\u2019s setup is \u201cvery interesting and very pragmatic\u201d and \u201csuitable for our drug,\u201d he\u2019s worried about getting on the wrong side of the FDA.<\/p>\n<p>DeVault has been pleading with FDA staffers for a written statement essentially promising that biotech companies participating in Montana\u2019s program won\u2019t be penalized later on, especially when they eventually try to get their drugs approved in the US. But he hasn\u2019t made any progress.<\/p>\n<p><strong>Now he\u2019s looking beyond Montana.<\/strong> He\u2019s considering accessing treatment in Pr\u00f3spera, a private city and \u201cspecial economic zone\u201d in Roat\u00e1n, Honduras, where a clinic sells unproven stem-cell and gene therapies, among others.<\/p>\n<p>Many scientists have cautioned against the use of such \u201coffshore\u201d clinics. Even when it comes to Montana, scientists, bioethicists, and health law experts will caution that phase I clinical trials don\u2019t prove a drug is safe. And they certainly don\u2019t prove a drug\u2019s efficacy, either.<\/p>\n<p>When I spoke to Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation, about the Montana law earlier this week, he made his concerns clear. \u201cPatients who want these kinds of treatments deserve them to be rigorously assessed so that [they] can better understand what they\u2019re getting themselves into, and what they\u2019re paying their hard-earned money for.\u201d<\/p>\n<p><strong>But DeVault pushes back on these arguments.<\/strong> \u201cI\u2019m a full-grown human being,\u201d he says. \u201cI\u2019m capable of going to Vegas right now \u2026 blowing it all on the poker table, [or] I can go to the gun shop and buy a silenced [semi-automatic rifle] \u2026 how come I can\u2019t make a decision to purchase a potential treatment that might change the entire trajectory of my son\u2019s life?\u201d<\/p>\n<p><em>This article first appeared in The Checkup,\u00a0<\/em>MIT Technology Review\u2019s<em>\u00a0weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first,\u00a0<\/em><a href=\"https:\/\/forms.technologyreview.com\/newsletters\/biotech-the-checkup\/?_ga=2.241810882.15113993.1664981064-43237434.1647441349\"><em>sign up here<\/em><\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Kris DeVault is desperate. His son, Brody, was born in March 2023. It wasn\u2019t long before he started to show signs of developmental delay, says DeVault. As time went on, Brody started missing key milestones in speech, movement, and coordination, he says. When Brody was around two and a half years old, a genetic test revealed creatine transporter deficiency\u2014a rare condition in which the brain and muscles lack the energy they need to develop. There are no cures for Brody\u2019s condition. But DeVault has learned of a company developing a drug that might help. That drug is still in the early stages of development and has only been tested in animals and a small number of healthy adults. Doctors can\u2019t prescribe it. DeVault knows the drug might not work. But he\u2019s doing all he can to access it regardless. And a new law in Montana could make it easier for people in his position to get access to treatments\u2014at least in theory. Today, Brody is three years old. His dad describes him as a happy, curious, and loving little boy who wants to learn. But Brody struggles to communicate. \u201cHe\u2019s got no words, really,\u201d says DeVault. \u201cHe wants to communicate more than he\u2019s able to \u2026 which then turns into frustration.\u201d It\u2019s difficult for Brody to tell his parents whether he\u2019s hot, cold, hungry, thirsty, uncomfortable, or even in pain, says DeVault. He recently found Brody standing on an anthill in the backyard, being bitten by red ants. \u201cThese fire ants were just going to town on his feet \u2026 and he was just looking,\u201d he says. Brody has muscle weakness too. \u201cHe can\u2019t move very fast, he doesn\u2019t have a ton of strength \u2026 and it takes a lot of energy for him to walk balanced,\u201d says DeVault. \u201cHis arms are skinnier than [those of] his nine-month-old sister.\u201d It\u2019s concerning, but DeVault is most worried about Brody\u2019s neurological development. Toddlers\u2019 brains are exceptionally \u201cplastic\u201d\u2014the first years of a child\u2019s life are thought to be\u00a0crucial for long-term brain development. A biotechnology company in France is working on a drug to help people like Brody. Creatine usually provides brain cells with energy. People with creatine transporter deficiency (CTD) can\u2019t get creatine into the brain. The team at Ceres Brain Therapeutics is developing a treatment designed to bypass this issue and effectively deliver creatine directly to the brain. So far, the team has seen promising results in mice, says Ceres CEO Thomas Joudinaud. The company also recently completed a phase I clinical trial that involved testing various doses of the drug, which is delivered as a nasal spray, in 48 healthy adult volunteers. That trial has not yet been published, says Joudinaud. The drug has not been tested in people with CTD, or in children. \u201cI look at this, and I\u2019m like, that is my one shot for Brody,\u201d says DeVault. Kris DeVault, his son Brody, and his wife and young daughter.COURTESY OF THE DEVAULT FAMILY Joudinaud is planning a phase II trial in people with CTD, as well as others with amyotrophic lateral sclerosis. But that trial will take place in France, and it\u2019s unlikely that Brody will be able to take part, says DeVault. Ceres can\u2019t make the drug available to Brody under an expanded access scheme run by the US Food and Drug Administration either, because the drug has not been registered with the FDA, and because it is currently manufactured in a way that does not comply with FDA regulations, says Joudinaud. Even if that phase II trial is successful, and if the drug is ultimately approved, it is unlikely to reach the US market for at least a few years. DeVault is worried that will be too late for Brody\u2014he\u2019ll be \u201cpast his plasticity window\u201d by then, he says. Now, with the adoption of a new law in Montana, he theoretically has another option. Montana has had a \u201cright to try\u201d law\u2014which allows terminally ill people to apply for access to unapproved drugs\u2014in place since 2015. In 2023, a new law technically expanded this option to people who were not terminally ill, providing the drugs have been through preliminary phase I clinical trials. A second law aimed to clarify how clinics could sell and administer those treatments to patients. And last weekend, the state\u2019s department of Health and Human Services finalized a set of rules for those clinics. An experimental treatment review board (ETRB) has been established to review applications for access to experimental, unproven, and unapproved drugs. And it is set to review its first two applications in the coming weeks. Ceres could also apply to Montana\u2019s ETRB to sell its experimental treatment to Brody\u2019s parents via a clinic in the state. But Joudinaud is reluctant, at least for the time being. While he thinks that Montana\u2019s setup is \u201cvery interesting and very pragmatic\u201d and \u201csuitable for our drug,\u201d he\u2019s worried about getting on the wrong side of the FDA. DeVault has been pleading with FDA staffers for a written statement essentially promising that biotech companies participating in Montana\u2019s program won\u2019t be penalized later on, especially when they eventually try to get their drugs approved in the US. But he hasn\u2019t made any progress. Now he\u2019s looking beyond Montana. He\u2019s considering accessing treatment in Pr\u00f3spera, a private city and \u201cspecial economic zone\u201d in Roat\u00e1n, Honduras, where a clinic sells unproven stem-cell and gene therapies, among others. Many scientists have cautioned against the use of such \u201coffshore\u201d clinics. Even when it comes to Montana, scientists, bioethicists, and health law experts will caution that phase I clinical trials don\u2019t prove a drug is safe. And they certainly don\u2019t prove a drug\u2019s efficacy, either. When I spoke to Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation, about the Montana law earlier this week, he made his concerns clear. \u201cPatients who want these kinds of treatments deserve them to be rigorously assessed so that [they] can better understand what<\/p>","protected":false},"author":2,"featured_media":108166,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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