A new drug, created to treat just one patient, has pushed the bounds of personalized medicine and has raised unexplored regulatory and ethical questions, scientists reported Wednesday.
The drug, described in the New England Journal of Medicine, is believed to be the first “custom” treatment for a genetic disease. It is called milasen, named after the only patient who will ever take it: Mila (mee-lah) Makovec, who lives with her mother, Julia Vitarello, in Longmont, Colorado.
Mila, 8, has a rapidly progressing neurological disorder that is fatal. Her symptoms started at age 3. Within a few years, she had gone from an agile, talkative child to one who was blind and unable to stand or hold up her head. She needed a feeding tube and experienced up to 30 seizures a day, each lasting one or two minutes.
Vitarello learned in December 2016 that Mila had Batten’s disease. But the girl’s case was puzzling, doctors said. Batten’s disease is recessive — a patient must inherit two mutated versions of a gene, MFSD8, to develop the disease.
Mila had just one mutated gene, and the other copy seemed normal. That should have been sufficient to prevent the disease.
In March 2017, Dr. Timothy Yu and his colleagues at Boston Children’s Hospital discovered that the problem with the intact gene lay in an extraneous bit of DNA that had scrambled the manufacturing of an important protein.
That gave Yu an idea: Why not make a custom piece of RNA to block the effects of the extraneous DNA? Developing such a drug would be expensive, but there were no other options.
Vitarello already had set up Mila’s Miracle Foundation and was appealing for donations on GoFundMe. So, she began fundraising in earnest, eventually raising $3 million for a variety of research efforts.
Yu’s team oversaw development of the drug, tested it in rodents, and consulted with the Food and Drug Administration. In January 2018, the agency granted permission to give the drug to Mila. She got her first dose on Jan. 31, 2018.
The drug was delivered through a spinal tap, so it could reach her brain. Within a month, Vitarello noticed a difference. Mila was having fewer seizures, and they were not lasting as long.
With continued treatments, the number of seizures has diminished so much that the girl has between zero and six a day, and they last less than a minute.
Mila rarely needs the feeding tube now, and is able once again to eat puréed foods. She cannot stand unassisted, but when she is held upright, her neck and back are straight, no longer slumped.
Still, Mila has lost the last few words of her vocabulary and remains severely disabled.
“She is starting not to respond to things that made her laugh or smile,” Vitarello said.
Milasen is believed to be the first drug developed for a single patient (CAR-T cancer therapies, while individualized, are not drugs). But the path forward is not clear, Yu and his colleagues acknowledged.
There are more than 7,000 rare diseases, and more than 90% have no FDA-approved treatment, according to Rachel Sher, vice president of regulatory and government affairs at the National Organization for Rare Disorders.
Tens of thousands of patients could be in Mila’s situation in the United States alone. But there are nowhere near enough researchers to make custom drugs for all who might want them.
And even if there were, who would pay? Not the federal government, not drug companies and not insurers, said Dr. Steven Joffe, professor of medical ethics and health policy at the University of Pennsylvania.
“Unfortunately, that leaves it to families,” he added. “It feels awfully uncomfortable, but that is the reality.”
That means custom drugs would be an option only for the very wealthy, those with the skills to raise large sums of money, or those who gain the support of foundations.
Mila’s drug development was mostly paid for by the foundation run by her mother, but she and Yu declined to say how much was spent.
The idea of custom drugs also leads the FDA into uncharted territory. In an editorial published with Yu’s paper, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, raised tough questions:
What type of evidence is needed before exposing a human to a new drug? Even in rapidly progressing, fatal illnesses, precipitating severe complications or death is not acceptable, so what is the minimum assurance of safety that is needed?
She also asked how a custom drug’s efficacy might be evaluated, and how regulators should weigh the urgency of the patient’s situation and the number of patients who could ultimately be treated. None of those questions have an easy answer.
Brad Margus, founder of the A-T Children’s Project, said he was hoping Yu would develop another custom drug for a 2-year-old girl with A-T, or ataxia telangiectasia, an extremely rare genetic disorder that causes a variety of symptoms, including problems moving, a weakened immune system and slowed mental development. Margus’ two sons have A-T.
His foundation would pay for the work, although the drug would be suitable for only one child. But Margus wondered how generalizable the custom-drug approach would be for “patients whose parents or disease advocates haven’t been lucky enough to capture a slice of Tim Yu’s time.”
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Milasen will not cure Mila, Vitarello acknowledged. But Mila was 7 when she got her first dose.
“What if the next Mila is treated when she is 4 or 5?” she asked. The development of milasen “is opening up an entirely new treatment path.”
“As a mom, I still feel hopeful,” Vitarello added. “But I have one foot in hope and one foot in reality.”
2019年10月19日 18:22
7276549
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2019年10月19日 17:46
7990232
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2019年10月19日 17:32
7258112
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2019年10月19日 16:37
7600773
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2019年10月19日 16:18
7920367
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2019年10月19日 15:46
7281684
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2019年10月19日 15:33
7802128
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2019年10月19日 14:59
http://pillsgen.site scintillae , trustworthy , contest
2019年10月19日 14:57
7978952
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2019年10月19日 14:06
7257434
https://www.livelib.ru/selection/1476740-vetrenyj-17-seriya-russkaya-ozvuchka-hercai-vetrenyj-17-18-19-seriya http://androwar.xhost.ro/index.php?topic=13467.0 http://gyroroue-quebec.com/index.php?topic=638419.0 http://www.electronoobs.com/QA/index.php?qa=57996&qa_1=%D0%BD%D0%B0%D0%BB%D0%B5%D1%82-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-%D1%81%D0%B5%D1%80%D0%B8%D1%8F-j9-%D0%BD%D0%B0%D0%BB%D0%B5%D1%82-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-%D1%81%D0%B5%D1%80%D0%B8%D1%8F%E3%80%91-%D0%BD%D0%B0%D0%BB%D0%B5%D1%82-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-%D1%81%D0%B5%D1%80%D0%B8%D1%8F-n9 http://www.scrc.co.kr/bd_news/864913 http://153.120.114.241/eso/index.php/20931614-papik-papik-2-seria-h3-papik-papik-2-seria-papik-papik-2-seria- http://www.kasct.org/xe/photo_1/1085300 http://www.scrc.co.kr/bd_news/902008 http://www.remify.app/foro/index.php?topic=1115856.0 http://csrhubindia.org/index.php/component/k2/itemlist/user/42219 https://wikivay.com/Th%C3%A0nh_vi%C3%AAn:MervinCannon2 http://withinfp.sakura.ne.jp/eso/index.php/20933661-test-na-beremennost-2-sezon-2-seria-f1-test-na-beremennost-2-se https://corpex.info/forum/index.php?topic=5134.0 https://www.sudurdergisi.xyz/index.php?topic=218829.0 http://www.xn--72czjh7b7bh0der4k.com/index.php?topic=16758.0 http://pacochatube.phorum.pl/viewtopic.php?f=1&t=205154 http://imfl.sci.pfu.edu.ru/forum/index.php?action=profile;u=385462 http://www.ortovivaistica.it/component/k2/itemlist/user/21932 http://gyroroue-quebec.com/index.php?topic=639593.0 http://www.hulyacb.com/index.php/component/k2/itemlist/user/96775 http://www.scrc.co.kr/bd_news/917373 https://cursosenlaweb.es/%d0%b8%d0%b2%d0%b0%d0%bd%d0%be%d0%b2%d1%8b-%d0%b8%d0%b2%d0%b0%d0%bd%d0%be%d0%b2%d1%8b-4-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-1-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-n4-%e3%80%90-%d0%b8%d0%b2%d0%b0/ https://fotokurskalmar.se/forum/index.php?topic=7991.0 http://help.stv.ru/index.php?topic=219451.0 http://forum.eingeing.com/index.php?topic=88762.0 http://www.scrc.co.kr/bd_news/916423 http://hope.bisandong.net/donations/997268 http://ampletree87.godohosting.com/board_cjnT22/338502 http://ampletree87.godohosting.com/board_cjnT22/319970 https://cursosenlaweb.es/?p=196289 http://forum.eingeing.com/index.php?topic=90508.0 http://www.scrc.co.kr/bd_news/885050 http://forum.eingeing.com/index.php?topic=89987.0 http://212.22.93.117/forum/index.php?topic=79399.0 http://dialog-vremen.ru/component/k2/itemlist/user/12075 http://tehnoid.com/forum/index.php?topic=85342.0 http://kknt.edu.my/index.php/component/k2/itemlist/user/141521 http://shakimuddin.com/component/k2/itemlist/user/1694794 http://androwar.xhost.ro/index.php?topic=12874.0 http://forum.metliefdevoor.nl/index.php?topic=59558.0 http://help.stv.ru/index.php?PHPSESSID=a2e60dfc7d2b370482ea94da1e989b15&topic=220359.0 http://ampletree87.godohosting.com/board_cjnT22/332453 http://ampletree87.godohosting.com/board_cjnT22/333072 http://www.scrc.co.kr/bd_news/901331 https://www.sudurdergisi.xyz/index.php?topic=219445.0 http://153.120.114.241/eso/index.php/20935838-prestuplenie-2-sezon-2-seria-online-f8-prestuplenie-2-sezon-2-s http://withinfp.sakura.ne.jp/eso/index.php/20945510-doktor-rihter-3-sezon-2-seria-watch-i0-doktor-rihter-3-sezon-2-/0 kdhfkse74y3dh
2019年10月19日 13:32
7276972
https://www.livelib.ru/selection/1476740-vetrenyj-17-seriya-russkaya-ozvuchka-hercai-vetrenyj-17-18-19-seriya http://forum.byehaj.hu/index.php?topic=211312.0 http://forum.metliefdevoor.nl/index.php?topic=64018.0 http://forum.metliefdevoor.nl/index.php?topic=64110.0 http://forum.zplay.cz/index.php?topic=47258.0 http://forum.zplay.cz/index.php?topic=47270.0 http://forum.zplay.cz/index.php?topic=47316.0 http://forum.zplay.cz/index.php?topic=47354.0 http://fuamex.com/2019/10/%d0%b2%d0%b0%d0%bd-%d1%85%d0%b5%d0%bb%d1%8c%d1%81%d0%b8%d0%bd%d0%b3-4-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-5-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-bon-%d0%b2%d0%b0%d0%bd-%d1%85%d0%b5%d0%bb%d1%8c%d1%81/ http://hope.bisandong.net/?document_srl=1108379 http://hope.bisandong.net/donations/1108310 http://hope.bisandong.net/donations/1108648 http://hope.bisandong.net/donations/1108769 http://immobilia.gr/index.php/component/k2/itemlist/user/31791 http://loaspain.es/Foro/index.php?topic=47669.0 http://maler-klumpp.de/?option=com_k2&view=itemlist&task=user&id=2187674 http://sesao19.go.th/web/qa/index.php?topic=6477.0 http://syntaxzone.com/index.php?topic=12273.0 http://syntaxzone.com/index.php?topic=12276.0 http://syntaxzone.com/index.php?topic=12283.0 http://syntaxzone.com/index.php?topic=12287.0 https://corpex.info/forum/index.php?topic=6457.0 https://design.yju.ac.kr/board_VSup99/837512 https://design.yju.ac.kr/board_VSup99/837700 https://fotokurskalmar.se/forum/index.php?action=profile;u=9182 https://koni62.ru/forum/index.php?topic=66641.0 https://koni62.ru/forum/index.php?topic=66660.0 https://koni62.ru/forum/index.php?topic=66667.0 https://koni62.ru/forum/index.php?topic=66669.0 https://mediccoin.com/forum/index.php?topic=114789.0 https://promoslots.ru/index.php?topic=107436.0 https://promoslots.ru/index.php?topic=107453.0 https://webuyhouseswithcashmoney.com/forum/index.php?topic=66118.0 https://webuyhouseswithcashmoney.com/forum/index.php?topic=66261.0 https://www.laurel-e-hardy.it/forum/index.php?topic=23522.0 https://www.suratlink.com/board/index.php?topic=10556.0 https://www.swiss-focus.ch/?option=com_k2&view=itemlist&task=user&id=547931 http://1.179.184.26:8000/itart/index.php?topic=4155.0 http://1.179.184.26:8000/itart/index.php?topic=4156.0 http://1.179.184.26:8000/itart/index.php?topic=4157.0 http://1.179.184.26:8000/itart/index.php?topic=4159.0 http://1.179.184.26:8000/itart/index.php?topic=4161.0 http://212.22.93.117/forum/index.php?topic=95759.0 http://212.22.93.117/forum/index.php?topic=95794.0 http://212.22.93.117/forum/index.php?topic=95812.0 http://212.22.93.117/forum/index.php?topic=95817.0 http://androwar.xhost.ro/index.php?topic=24081.0 http://androwar.xhost.ro/index.php?topic=24108.0 http://androwar.xhost.ro/index.php?topic=24143.0 http://angel-com027.shop/?document_srl=615852 http://angel-com027.shop/?document_srl=616550 http://angel-com027.shop/?document_srl=616879 http://angel-com027.shop/?document_srl=617137 http://angel-com027.shop/index.php?document_srl=614733&mid=s2 http://esports.startapphub.id/index.php?topic=22916.0 http://esports.startapphub.id/index.php?topic=23052.0 kdhfkse74y3dh
2019年10月19日 13:11
7383271
https://www.livelib.ru/selection/1476740-vetrenyj-17-seriya-russkaya-ozvuchka-hercai-vetrenyj-17-18-19-seriya http://csrhubindia.org/index.php/component/k2/itemlist/user/40218 http://help.stv.ru/index.php?PHPSESSID=26b732ede535482d4dc70787e28cd9ac&topic=222106.0 http://www.scrc.co.kr/bd_news/908831 http://212.22.93.117/forum/index.php?topic=82031.0 http://tehnoid.com/forum/index.php?topic=83387.0 https://design.yju.ac.kr/board_VSup99/780976 http://help.stv.ru/index.php?topic=222172.0 https://corpex.info/forum/index.php?topic=5052.0 https://www.missionnairessansfrontiere.org/?option=com_k2&view=itemlist&task=user&id=14859 https://foroaoe.com/index.php?topic=3469.0 http://fuamex.com/2019/10/%d1%8d%d1%82%d0%be-%d0%bc%d1%8b-4-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-3-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-fol-%d1%8d%d1%82%d0%be-%d0%bc%d1%8b-4-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-3-%d1%81%d0%b5%d1%80/ http://www.scrc.co.kr/bd_news/877415 https://kommunarka-1.ru/forum/index.php?topic=23237.0 http://www.scrc.co.kr/bd_news/920625 http://androwar.xhost.ro/index.php?topic=12832.0 https://x3exchange.com/%d1%82%d0%b5%d1%81%d1%82-%d0%bd%d0%b0-%d0%b1%d0%b5%d1%80%d0%b5%d0%bc%d0%b5%d0%bd%d0%bd%d0%be%d1%81%d1%82%d1%8c-2-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-1-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-l1-%e3%80%90-%d1%82/ https://foroaoe.com/index.php?topic=3471.0 https://mediccoin.com/forum/index.php?topic=108453.0 http://shakimuddin.com/?option=com_k2&view=itemlist&task=user&id=1696932 http://imfl.sci.pfu.edu.ru/forum/index.php?topic=117406.0 https://dospuntoseventos.cl/?option=com_k2&view=itemlist&task=user&id=973349 http://www.rrinternationalcollege.in/component/k2/itemlist/user/76540 http://oabvr.org.br/?option=com_k2&view=itemlist&task=user&id=110799 http://www.remify.app/foro/index.php?topic=1117150.0 http://tehnoid.com/forum/index.php?topic=78902.0 http://www.fixdrive.nhely.hu/index.php?topic=59846.0 https://cursosenlaweb.es/%d0%b4%d0%b5%d1%82%d0%b8-%d1%81%d0%b5%d1%81%d1%82%d0%b5%d1%80-kardes-cocuklari-2-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-22-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-17-10-2019-flj-%d0%b4%d0%b5%d1%82/ http://1.179.184.26:8000/itart/index.php?topic=2811.0 http://www.scrc.co.kr/bd_news/923045 http://forum.bbgs.org/index.php?topic=18953.0 http://androwar.xhost.ro/index.php?topic=12890.0 http://www.scrc.co.kr/bd_news/918639 http://forum.metliefdevoor.nl/index.php?topic=59863.0 http://www.albarefrigeration.com/index.php/component/k2/itemlist/user/20600 http://dialog-vremen.ru/component/k2/itemlist/user/11884 http://csrhubindia.org/index.php/component/k2/itemlist/user/40715 https://cursosenlaweb.es/%d1%81%d0%b8%d0%b4%d0%be%d1%80%d0%b5%d0%bd%d0%ba%d0%b8-%d1%81%d0%b8%d0%b4%d0%be%d1%80%d0%b5%d0%bd%d0%ba%d0%b8-1-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-l9-%e3%80%90-%d1%81%d0%b8%d0%b4%d0%be%d1%80%d0%b5%d0%bd/ http://hope.bisandong.net/donations/994833 https://design.yju.ac.kr/board_VSup99/781998 https://cursosenlaweb.es/%d1%80%d0%b5%d0%b1%d0%b5%d0%bd%d0%be%d0%ba-cocuk-8-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-%d0%bf%d0%b5%d1%80%d0%b5%d0%b2%d0%be%d0%b4-%d0%bd%d0%b0-%d1%80%d1%83%d1%81%d1%81%d0%ba%d0%be%d0%bc-o1/ http://www.kasct.org/xe/photo_1/1096537 http://forum.eingeing.com/index.php?topic=90569.0 http://www.medomedya.com/index.php?topic=69814.0 https://cursosenlaweb.es/%d0%b4%d0%b5%d1%82%d0%b8-%d1%81%d0%b5%d1%81%d1%82%d0%b5%d1%80-kardes-cocuklari-2-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-30-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-%d1%80%d1%83%d1%81-%d1%8f%d0%b7-i4/ http://help.stv.ru/index.php?PHPSESSID=3ccc1eae100987c5eebcb540510067bd&topic=220804.0 https://www.sudurdergisi.xyz/index.php?topic=217515.0 http://ampletree87.godohosting.com/board_cjnT22/318452 http://epes-ui.indojepang.com/index.php/component/k2/itemlist/user/741347 http://www.scrc.co.kr/?document_srl=866392 http://esports.startapphub.id/index.php?topic=16085.0 http://forum.bbgs.org/index.php?topic=18248.0 kdhfkse74y3dh
2019年10月19日 12:39
7818127
https://www.livelib.ru/selection/1476739-vetrenyj-1718-seriya-russkaya-ozvuchka-hercai-vetrenyj-17-18-19-seriya http://syntaxzone.com/index.php?topic=11639.0 http://syntaxzone.com/index.php?topic=11643.0 http://syntaxzone.com/index.php?topic=11653.0 http://syntaxzone.com/index.php?topic=11657.0 http://topitop.kz/index.php/component/k2/itemlist/user/118701 http://vl-game.info//index.php?topic=14123.0 http://vl-game.info//index.php?topic=14125.0 http://www.crb.udmyuki.ru/?option=com_k2&view=itemlist&task=user&id=21445 http://www.crb.udmyuki.ru/?option=com_k2&view=itemlist&task=user&id=21514 http://www.ergoplus.it/?option=com_k2&view=itemlist&task=user&id=1211688 http://www.eventimarlene.com/?option=com_k2&view=itemlist&task=user&id=1713170 http://www.fairfightclan.com/forum/index.php?topic=41796.0 http://www.fairfightclan.com/forum/index.php?topic=41818.0 http://www.fairfightclan.com/forum/index.php?topic=41833.0 http://www.onoranzefunebridalsasso.it/index.php/component/k2/itemlist/user/115434 http://www.ortovivaistica.it/component/k2/itemlist/user/22440 http://www.telcon.gr/?option=com_k2&view=itemlist&task=user&id=524893 http://www.telcon.gr/?option=com_k2&view=itemlist&task=user&id=524939 http://www.telcon.gr/?option=com_k2&view=itemlist&task=user&id=524979 http://www.telcon.gr/?option=com_k2&view=itemlist&task=user&id=525046 http://www.vivelabmanizales.com/%d0%b7%d0%b0%d0%bf%d1%80%d0%b5%d1%82%d0%bd%d1%8b%d0%b9-%d0%bf%d0%bb%d0%be%d0%b4-yasak-elma-3-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-57-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-%d1%80%d1%83%d1%81%d1%81-3/ https://chatgrupo.com/foro/index.php?topic=317278.0 https://design.yju.ac.kr/?document_srl=824533 https://design.yju.ac.kr/board_VSup99/825199 https://design.yju.ac.kr/board_VSup99/825249 https://dospuntoseventos.cl/?option=com_k2&view=itemlist&task=user&id=984380 https://forum.mlmtokenizer.com/index.php?topic=50566.0 https://forum.mlmtokenizer.com/index.php?topic=50642.0 https://forum.mlmtokenizer.com/index.php?topic=50683.0 https://forum.mlmtokenizer.com/index.php?topic=50695.0 https://grupojuridicosas.com/foro/index.php?topic=190278.0 https://koni62.ru/forum/index.php?topic=65871.0 https://mediccoin.com/forum/index.php?topic=112948.0 https://webuyhouseswithcashmoney.com/forum/index.php?topic=64248.0 https://webuyhouseswithcashmoney.com/forum/index.php?topic=64291.0 https://webuyhouseswithcashmoney.com/forum/index.php?topic=64303.0 https://www.laurel-e-hardy.it/forum/index.php?topic=22754.0 https://www.missionnairessansfrontiere.org/index.php/component/k2/itemlist/user/15728 https://www.regalepadova.it/index.php/component/k2/itemlist/user/23357 https://www.suratlink.com/board/index.php?topic=10085.0 https://www.swiss-focus.ch/?option=com_k2&view=itemlist&task=user&id=546481 https://www.swiss-focus.ch/?option=com_k2&view=itemlist&task=user&id=546623 https://www.swiss-focus.holderegger.info/?option=com_k2&view=itemlist&task=user&id=545908 http://1.179.184.26:8000/itart/index.php?topic=3876.0 http://212.96.116.6/index.php?PHPSESSID=4f9e0048e119a214593ba5b8757a5d26&topic=223679.0 http://212.96.116.6/index.php?PHPSESSID=6241a22dfeefeb8e0d790262c6c5f843&topic=223684.0 http://212.96.116.6/index.php?PHPSESSID=666e494c31d0f25b5a0b33d2de151dc0&topic=223643.0 http://accumaxeng.com/index.php/component/k2/itemlist/user/24452 http://accumaxeng.com/index.php/component/k2/itemlist/user/24482 http://ampletree87.godohosting.com/board_cjnT22/367905 http://ampletree87.godohosting.com/board_cjnT22/368129 http://ampletree87.godohosting.com/board_cjnT22/368153 http://ampletree87.godohosting.com/board_cjnT22/368311 kdhfkse74y3dh
2019年10月19日 12:07
5562311
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wqqhed745974
2019年10月19日 11:50
7989901
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2019年10月19日 11:39
5772162
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2019年10月19日 11:38
A new drug, created to treat just one patient, has pushed the bounds of personalized medicine and has raised unexplored regulatory and ethical questions, scientists reported Wednesday.
The drug, described in the New England Journal of Medicine, is believed to be the first “custom” treatment for a genetic disease. It is called milasen, named after the only patient who will ever take it: Mila (mee-lah) Makovec, who lives with her mother, Julia Vitarello, in Longmont, Colorado.
Mila, 8, has a rapidly progressing neurological disorder that is fatal. Her symptoms started at age 3. Within a few years, she had gone from an agile, talkative child to one who was blind and unable to stand or hold up her head. She needed a feeding tube and experienced up to 30 seizures a day, each lasting one or two minutes.
Vitarello learned in December 2016 that Mila had Batten’s disease. But the girl’s case was puzzling, doctors said. Batten’s disease is recessive — a patient must inherit two mutated versions of a gene, MFSD8, to develop the disease.
Mila had just one mutated gene, and the other copy seemed normal. That should have been sufficient to prevent the disease.
In March 2017, Dr. Timothy Yu and his colleagues at Boston Children’s Hospital discovered that the problem with the intact gene lay in an extraneous bit of DNA that had scrambled the manufacturing of an important protein.
That gave Yu an idea: Why not make a custom piece of RNA to block the effects of the extraneous DNA? Developing such a drug would be expensive, but there were no other options.
Vitarello already had set up Mila’s Miracle Foundation and was appealing for donations on GoFundMe. So, she began fundraising in earnest, eventually raising $3 million for a variety of research efforts.
Yu’s team oversaw development of the drug, tested it in rodents, and consulted with the Food and Drug Administration. In January 2018, the agency granted permission to give the drug to Mila. She got her first dose on Jan. 31, 2018.
The drug was delivered through a spinal tap, so it could reach her brain. Within a month, Vitarello noticed a difference. Mila was having fewer seizures, and they were not lasting as long.
With continued treatments, the number of seizures has diminished so much that the girl has between zero and six a day, and they last less than a minute.
Mila rarely needs the feeding tube now, and is able once again to eat puréed foods. She cannot stand unassisted, but when she is held upright, her neck and back are straight, no longer slumped.
Still, Mila has lost the last few words of her vocabulary and remains severely disabled.
“She is starting not to respond to things that made her laugh or smile,” Vitarello said.
Milasen is believed to be the first drug developed for a single patient (CAR-T cancer therapies, while individualized, are not drugs). But the path forward is not clear, Yu and his colleagues acknowledged.
There are more than 7,000 rare diseases, and more than 90% have no FDA-approved treatment, according to Rachel Sher, vice president of regulatory and government affairs at the National Organization for Rare Disorders.
Tens of thousands of patients could be in Mila’s situation in the United States alone. But there are nowhere near enough researchers to make custom drugs for all who might want them.
And even if there were, who would pay? Not the federal government, not drug companies and not insurers, said Dr. Steven Joffe, professor of medical ethics and health policy at the University of Pennsylvania.
“Unfortunately, that leaves it to families,” he added. “It feels awfully uncomfortable, but that is the reality.”
That means custom drugs would be an option only for the very wealthy, those with the skills to raise large sums of money, or those who gain the support of foundations.
Mila’s drug development was mostly paid for by the foundation run by her mother, but she and Yu declined to say how much was spent.
The idea of custom drugs also leads the FDA into uncharted territory. In an editorial published with Yu’s paper, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, raised tough questions:
What type of evidence is needed before exposing a human to a new drug? Even in rapidly progressing, fatal illnesses, precipitating severe complications or death is not acceptable, so what is the minimum assurance of safety that is needed?
She also asked how a custom drug’s efficacy might be evaluated, and how regulators should weigh the urgency of the patient’s situation and the number of patients who could ultimately be treated. None of those questions have an easy answer.
Brad Margus, founder of the A-T Children’s Project, said he was hoping Yu would develop another custom drug for a 2-year-old girl with A-T, or ataxia telangiectasia, an extremely rare genetic disorder that causes a variety of symptoms, including problems moving, a weakened immune system and slowed mental development. Margus’ two sons have A-T.
His foundation would pay for the work, although the drug would be suitable for only one child. But Margus wondered how generalizable the custom-drug approach would be for “patients whose parents or disease advocates haven’t been lucky enough to capture a slice of Tim Yu’s time.”
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Milasen will not cure Mila, Vitarello acknowledged. But Mila was 7 when she got her first dose.
“What if the next Mila is treated when she is 4 or 5?” she asked. The development of milasen “is opening up an entirely new treatment path.”
“As a mom, I still feel hopeful,” Vitarello added. “But I have one foot in hope and one foot in reality.”
2019年10月19日 11:31
7906267
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http://fullgluesticky.riddled.y.n.a.m.i.c.t.r.a@p.a.ra.ll.e.lzora@Gal.EHi.Nt.on78.8.27@www.mondaymorninginspiration@fen.Gku.an.gx.r.ku.ai8.xn%E2%80%94.xn%E2%80%94.u.k@Meli.S.a.Ri.c.h4223@e.xultan.tacoustic.sfat.lettuceerz@fault.ybeamdulltnderwearertwe.s.e@p.laus.i.bleljh@r.eces.si.v.e.x.g.z@leanna.langton@blank.e.tu.y.z.s@m.i.scbarne.s.w@e.xped.it.io.n.eg.d.g@burton.rene@e.xped.it.io.n.eg.d.g@burton.rene@Gal.EHi.Nt.on78.8.27@dfu.s.m.f.h.u8.645v.nb@WWW.EMEKAOLISA@carlton.theis@silvia.woodw.o.r.t.h@s.jd.u.eh.yds.g.524.87.59.68.4@Sus.ta.i.n.j.ex.k@www.mondaymorninginspiration@irritatingfifthsimp.listichol.e.e@l.iv.eli.ne.s.swxzu@hu.feng.ku.angn.i.ub.i...u.k37@j.rwl1.o8.v.u9a5.3g@Www.Zanele@silvia.woodw.o.r.t.h@l.iv.eli.ne.S.swxzu@hu.feng.ku.angn.i.ub.i...u.k37@miquel.bueno@b.r.e.akableactorg.iganticp.rofite.r@simplis.ticholem.e.l.l.o.w.l.u.n.c.h.r.o.o.m.e@hsn.djuf.s.k.5.358.7.4.96.8.5@lgdc.maho.online/?qa=450390/%D0%BC%D0%B0%D0%B9%D1%8F%D0%BD%D1%86%D1%8B-2-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-7-%D1%81%D0%B5%D1%80%D0%B8%D1%8F-tku-%D0%BC%D0%B0%D0%B9%D1%8F%D0%BD%D1%86%D1%8B-2-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-7-%D1%81%D0%B5%D1%80%D0%B8%D1%8F 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2019年10月19日 11:00
7644106
https://www.livelib.ru/selection/1476739-vetrenyj-1718-seriya-russkaya-ozvuchka-hercai-vetrenyj-17-18-19-seriya http://forum.zplay.cz/index.php?topic=47886.0 http://forum.zplay.cz/index.php?topic=47914.0 http://gyroroue-quebec.com/index.php?topic=654526.0 http://gyroroue-quebec.com/index.php?topic=654598.0 http://gyroroue-quebec.com/index.php?topic=654620.0 http://gyroroue-quebec.com/index.php?topic=654664.0 http://help.stv.ru/index.php?PHPSESSID=4fb34c19b88adb45e9258c69895be6a4&topic=225517.0 http://help.stv.ru/index.php?PHPSESSID=a225446d14c295d697bf61ee029c4736&topic=225534.0 http://help.stv.ru/index.php?PHPSESSID=c3ce93b591063c9ce30a3097ab99b5b2&topic=225543.0 http://help.stv.ru/index.php?PHPSESSID=ca9ea34fc6c7d7ddffac0d79983598cd&topic=225538.0 http://help.stv.ru/index.php?PHPSESSID=cbd032724c3be67a17cad9eda8dcf688&topic=225552.0 http://praisecovenantministry.org/en/component/k2/itemlist/user/36472 http://pusheshgostar.com/?option=com_k2&view=itemlist&task=user&id=80596 http://shettyholidays.com/index.php/component/k2/itemlist/user/389082 http://shreekariisolutions.com/index.php/component/k2/itemlist/user/27039 http://smftezodevi.ml/index.php?topic=194455.0 http://spaceinteriors.in/?option=com_k2&view=itemlist&task=user&id=41029 http://spb.sdare.ru/?option=com_k2&view=itemlist&task=user&id=466645 http://svcorporation.in/?option=com_k2&view=itemlist&task=user&id=28074 http://topitop.kz/index.php/component/k2/itemlist/user/119099 http://www.crayfishthai.com/index.php?topic=81797.0 http://www.crayfishthai.com/index.php?topic=81809.0 http://www.crayfishthai.com/index.php?topic=81838.0 http://www.crayfishthai.com/index.php?topic=81856.0 http://www.crb.udmyuki.ru/?option=com_k2&view=itemlist&task=user&id=22550 http://www.electronoobs.com/QA/index.php?qa=59769&qa_1=%D0%BF%D0%B5%D1%81-%D1%81%D0%B5%D1%80%D0%B8%D0%B0%D0%BB-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-%D1%81%D0%B5%D1%80%D0%B8%D1%8F-%D1%81%D0%B5%D1%80%D0%B8%D0%B0%D0%BB-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-%D1%81%D0%B5%D1%80%D0%B8%D1%8F%E3%80%91-%D1%81%D0%B5%D1%80%D0%B8%D0%B0%D0%BB-%D1%81%D0%B5%D0%B7%D0%BE%D0%BD-%D1%81%D0%B5%D1%80%D0%B8%D1%8F http://www.electronoobs.com/QA/index.php?qa=59772&qa_1=%D0%BC%D1%8B%D1%88%D0%B5%D0%BB%D0%BE%D0%B2%D0%BA%D0%B0-%D1%81%D0%B5%D1%80%D0%B8%D1%8F-%D0%BC%D1%8B%D1%88%D0%B5%D0%BB%D0%BE%D0%B2%D0%BA%D0%B0-%D0%BA%D0%BE%D1%82%D0%B0-%D1%81%D0%B5%D1%80%D0%B8%D1%8F%E3%80%91-%D0%BC%D1%8B%D1%88%D0%B5%D0%BB%D0%BE%D0%B2%D0%BA%D0%B0-%D0%BA%D0%BE%D1%82%D0%B0-%D1%81%D0%B5%D1%80%D0%B8%D1%8F http://www.ergoplus.it/component/k2/itemlist/user/1213526 http://www.hulyacb.com/index.php/component/k2/itemlist/user/101898 http://www.onoranzefunebridalsasso.it/index.php/component/k2/itemlist/user/116464 http://www.remify.app/foro/index.php?topic=1119690.0 http://www.rrinternationalcollege.in/component/k2/itemlist/user/78570 http://www.telcon.gr/index.php/component/k2/itemlist/user/528257 https://design.yju.ac.kr/board_VSup99/839208 https://design.yju.ac.kr/board_VSup99/839293 https://design.yju.ac.kr/board_VSup99/840078 https://forum.mlmtokenizer.com/index.php?topic=52663.0 https://koni62.ru/forum/index.php?topic=66800.0 https://koni62.ru/forum/index.php?topic=66808.0 https://mediccoin.com/forum/index.php?topic=115081.0 https://mediccoin.com/forum/index.php?topic=115108.0 https://www.cytotecbrasil.net/forum/index.php?topic=44018.0 https://www.cytotecbrasil.net/forum/index.php?topic=44057.0 https://www.decorlandia-light.com/?option=com_k2&view=itemlist&task=user&id=13675 https://www.gtupuw.org/?option=com_k2&view=itemlist&task=user&id=3411013 https://www.suratlink.com/board/index.php?topic=10595.0 http://1.179.184.26:8000/itart/index.php?topic=4223.0 http://1.179.184.26:8000/itart/index.php?topic=4227.0 kdhfkse74y3dh
2019年10月19日 10:39
7200568
https://www.livelib.ru/selection/1476740-vetrenyj-17-seriya-russkaya-ozvuchka-hercai-vetrenyj-17-18-19-seriya http://shakimuddin.com/?option=com_k2&view=itemlist&task=user&id=1698058 http://shettyholidays.com/index.php/component/k2/itemlist/user/388299 http://shreekariisolutions.com/?option=com_k2&view=itemlist&task=user&id=26225 http://spaceinteriors.in/?option=com_k2&view=itemlist&task=user&id=39454 http://spaceinteriors.in/?option=com_k2&view=itemlist&task=user&id=39498 http://spb.sdare.ru/?option=com_k2&view=itemlist&task=user&id=463929 http://wixelent.co.kr/xe/ch_notice/151603 http://www.crayfishthai.com/index.php?topic=78306.0 http://www.hulyacb.com/index.php/component/k2/itemlist/user/100434 http://www.kasct.org/xe/photo_1/1109028 http://www.kasct.org/xe/photo_1/1109135 http://www.linene.co.kr/xe/inquire/9529 http://www.telcon.gr/?option=com_k2&view=itemlist&task=user&id=524492 http://www.telcon.gr/index.php/component/k2/itemlist/user/524309 http://www.vivelabmanizales.com/%d0%bc%d1%8b%d1%88%d0%b5%d0%bb%d0%be%d0%b2%d0%ba%d0%b0-%d0%b4%d0%bb%d1%8f-%d0%ba%d0%be%d1%82%d0%b0-3-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-w3-%e3%80%90-%d0%bc%d1%8b%d1%88%d0%b5%d0%bb%d0%be%d0%b2%d0%ba/ http://www.vivelabmanizales.com/%d1%81%d0%ba%d0%be%d1%80%d0%b0%d1%8f-%d0%bf%d0%be%d0%bc%d0%be%d1%89%d1%8c-2-%d1%81%d0%b5%d0%b7%d0%be%d0%bd-1-%d1%81%d0%b5%d1%80%d0%b8%d1%8f-l2-%e3%80%90-%d1%81%d0%ba%d0%be%d1%80%d0%b0%d1%8f-%d0%bf/ https://chatgrupo.com/foro/index.php?topic=317116.0 https://chatgrupo.com/foro/index.php?topic=317121.0 https://forum.mlmtokenizer.com/index.php?topic=50351.0 https://forum.mlmtokenizer.com/index.php?topic=50357.0 https://forum.mlmtokenizer.com/index.php?topic=50381.0 https://kommunarka-1.ru/forum/index.php?topic=25432.0 https://kommunarka-1.ru/forum/index.php?topic=25465.0 https://www.cytotecbrasil.net/forum/index.php?topic=43255.0 https://www.missionnairessansfrontiere.org/?option=com_k2&view=itemlist&task=user&id=15706 https://www.missionnairessansfrontiere.org/?option=com_k2&view=itemlist&task=user&id=15715 https://www.suratlink.com/board/index.php?topic=10024.0 https://www.suratlink.com/board/index.php?topic=10028.0 https://www.swiss-focus.holderegger.info/?option=com_k2&view=itemlist&task=user&id=545896 http://212.22.93.117/forum/index.php?topic=92662.0 http://212.22.93.117/forum/index.php?topic=92666.0 http://212.22.93.117/forum/index.php?topic=92710.0 http://accumaxeng.com/index.php/component/k2/itemlist/user/24221 http://accumaxeng.com/index.php/component/k2/itemlist/user/24267 http://ampletree87.godohosting.com/?document_srl=362221 http://ampletree87.godohosting.com/board_cjnT22/362125 http://ampletree87.godohosting.com/board_cjnT22/362625 http://ampletree87.godohosting.com/board_cjnT22/362816 http://ampletree87.godohosting.com/board_cjnT22/362836 http://ampletree87.godohosting.com/board_cjnT22/362995 http://ampletree87.godohosting.com/board_cjnT22/363286 http://ampletree87.godohosting.com/board_cjnT22/363321 http://ampletree87.godohosting.com/board_cjnT22/363495 http://ampletree87.godohosting.com/board_cjnT22/363554 http://androwar.xhost.ro/index.php?topic=21468.0 http://androwar.xhost.ro/index.php?topic=21488.0 http://androwar.xhost.ro/index.php?topic=21498.0 http://androwar.xhost.ro/index.php?topic=21513.0 http://androwar.xhost.ro/index.php?topic=21552.0 http://anipardakht.com/index.php/component/k2/itemlist/user/107192 http://anzvoice.com/index.php/component/k2/itemlist/user/31654 http://carairconindia.com/?option=com_k2&view=itemlist&task=user&id=20783 kdhfkse74y3dh