Health Law Could Be Hard to Knock Down Despite Judge’s Ruling

Could a federal judge in Texas be the catalyst that finally brings down the Affordable Care Act, a law that has withstood countless assaults from Republicans in Congress and two Supreme Court challenges?

On the morning after Judge Reed O’Connor’s startling ruling that struck down the landmark health law, legal scholars were doubtful.

Lawyers on both sides of previous A.C.A. battles said the reasoning behind this one was badly flawed, notably in its insistence that the entire 2010 law must fall because one of its provisions may have been rendered invalid by the 2017 tax overhaul legislation. Had Congress meant to take such radical action, they said, it would have said so at the time.

Legal experts also noted that the Supreme Court, where most people believe the case is headed, historically has been reluctant to strike down federal laws, particularly those that have become ingrained in the lives of millions of citizens.

Judge O’Connor, who was appointed by George W. Bush to the Federal District Court in Fort Worth, has ruled against laws supporting immigration, transgender and Native American rights. Conservative lawyers are known to choose his district to file cases, hoping he will fire opening salvos that propel their issues through the court system.

The crux of Judge O’Connor’s decision centered on the health law’s requirement that most people have health coverage or pay a tax penalty.

That tax penalty was effectively eliminated when Congress reduced its amount to zero in the tax legislation enacted last year. And once the tax penalty no longer stood, the so-called “individual mandate” was unconstitutional and the entire law had to fall, the judge reasoned in accepting the argument of the 20 states that brought the lawsuit challenging the legislation.

But an array of legal experts said that argument was unsound. Jonathan H. Adler, a conservative law professor at Case Western Reserve University in Cleveland, called that position “simply nonsensical” and said the judge’s conclusion was “hard to justify” and “surprisingly weak.”

He and others pointed to the fact that even though Congress erased the tax penalty, it did not touch the rest of the sprawling health act. A longstanding legal doctrine called “severability” holds that when a court excises one provision of a statute, it should leave the rest of the law in place unless Congress explicitly stated that the statute could not survive without that provision.

In this case Congress’s intention was particularly clear, legal experts said.

“Congress amended one provision of a 2,000 page law and did not touch the rest of the law so it is implausible to believe that Congress intended the rest of the law not to exist,” said Abbe R. Gluck, a health law expert at Yale Law School.

Judge O’ Connor also cited congressional intent, focusing on language from the 2010 law, which underscored the significance of the individual mandate to the entire act. But he largely ignored the 2017 congressional action. In essence, legal scholars said, he looked to one congressional view and not the more recent one.

And in so doing, he opened the door for House Democrats to intervene in successive appeals. On Saturday aides to Representative Nancy Pelosi, who is expected to become the next speaker of the House, said she would move quickly to notify the Trump administration that House Democrats intended to step in to defend the law in the case.

Nicholas Bagley, a health law expert at the University of Michigan, suggested that Judge O’Connor may not yet be done with the case. In a series of tweets on Saturday, Mr. Bagley noted that the judge had not yet addressed a handful of central issues in the suit, nor had he issued a final ruling indicating whether the act should fall immediately. Judge O’Connor could indeed hold onto the case before an appellate court takes it up.

But if he lets the case move forward, a likely timeline, according to many legal experts, is that the case will be taken up by the United States Court of Appeals for the Fifth Circuit in New Orleans this spring. If the Fifth Circuit upholds Judge O’Connor’s decision, the Supreme Court is likely to agree to hear the case in its term that starts in October 2019, with a decision in 2020. If the Fifth Circuit overturns the judge’s ruling and upholds the law, there is a good chance the Supreme Court would decline to even take the case, legal scholars said.

One law professor, Ilya Somin of George Mason University, criticized parts of the opinion, but said he was “a bit less confident about the outcome” because “the history of A.C.A.-related litigation is filled with surprises and failed predictions by experts.”

Among the observations flying about was the notion that the Supreme Court only rarely strikes down federal laws, and it is particularly reluctant to do so when the laws have been in place for years and affect millions of people. In fact, Chief Justice John G. Roberts Jr. wrote in his 2012 opinion upholding the health care law, that the court should err on the side of sustaining federal laws.

“As between two possible interpretations of a statute, by one of which it would be unconstitutional and by the other valid,” he wrote, quoting Justice Oliver Wendell Holmes Jr., “our plain duty is to adopt that which will save the act.”

The five justices who voted to uphold the law in a landmark 2012 case, including Justice Roberts, are all still on the court.

 

December 15, 2018

Sources: New York Times

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    1 February 14, 2019
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    1 February 12, 2019
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    1 February 12, 2019
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    A.I. Shows Promise as a Physician Assistant

    has tested a potential remedy for all-too-human frailties: artificial intelligence.</p><p>The system was highly accurate, the researchers said, and one day may assist doctors in diagnosing complex or rare conditions.</p><p>Drawing on the records of nearly 600,000 Chinese patients who had visited a pediatric hospital over an 18-month period, the vast collection of data used to train this new system highlights an advantage for China in the worldwide race toward artificial intelligence.</p><p>Because its population is so large — and because its privacy norms put fewer restrictions on the sharing of digital data — it may be easier for Chinese companies and researchers to build and train the “deep learning” systems that are rapidly changing the trajectory of health care.</p><p>Pooling health care data is a particularly difficult endeavor. Whereas researchers went to a single Chinese hospital for all the data they needed to develop their artificial-intelligence system, gathering such data from American facilities is rarely so straightforward.</p><p>“You have go to multiple places,” said Dr. George Shih, associate professor of clinical radiology at Weill Cornell Medical Center and co-founder of MD.ai, a company that helps researchers label data for A.I. services. “The equipment is never the same. You have to make sure the data is anonymized. Even if you get permission, it is a massive amount of work.”</p><p>Similar technologies are being built to automatically detect signs of illness and disease in X-rays, M.R.I.s and eye scans.</p><p>Using the technology, Dr. Kang Zhang, chief of ophthalmic genetics at the University of California, San Diego, has built systems that can analyze eye scans for hemorrhages, lesions and other signs of diabetic blindness. Ideally, such systems would serve as a first line of defense, screening patients and pinpointing those who need further attention.</p><p>Now Dr. Zhang and his colleagues have created a system that can diagnose an even wider range of conditions by recognizing patterns in text, not just in medical images. This may augment what doctors can do on their own, he said.</p><p>“In some situations, physicians cannot consider all the possibilities,” he said. “This system can spot-check and make sure the physician didn’t miss anything.”</p><p>The experimental system analyzed the electronic medical records of nearly 600,000 patients at the Guangzhou Women and Children’s Medical Center in southern China, learning to associate common medical conditions with specific patient information gathered by doctors, nurses and other technicians.</p><p>First, a group of trained physicians annotated the hospital records, adding labels that identified information related to certain medical conditions. The system then analyzed the labeled data.</p><p>Then the neural network was given new information, including a patient’s symptoms as determined during a physical examination. Soon it was able to make connections on its own between written records and observed symptoms.</p><p>When tested on unlabeled data, the software could rival the performance of experienced physicians. It was more than 90 percent accurate at diagnosing asthma; the accuracy of physicians in the study ranged from 80 to 94 percent.</p><p>In diagnosing gastrointestinal disease, the system was 87 percent accurate, compared with the physicians’ accuracy of 82 to 90 percent.</p><p>Able to recognize patterns in data that humans could never identify on their own, neural networks can be enormously powerful in the right situation. But even experts have difficulty understanding why such networks make particular decisions and how they teach themselves.</p><p>As a result, extensive testing is needed to reassure both doctors and patients that these systems are reliable.</p><p>Experts said extensive clinical trials are now needed for Dr. Zhang’s system, given the difficulty of interpreting decisions made by neural networks.</p><p>“Medicine is a slow-moving field,” said Ben Shickel, a researcher at the University of Florida who specializes in the use of deep learning for health care. “No one is just going to deploy one of these techniques without rigorous testing that shows exactly what is going on.”</p><p>It could be years before deep-learning systems are deployed in emergency rooms and clinics. But some are closer to real-world use: Google is now running clinical trials of its eye-scan system at two hospitals in southern India.</p><p>Deep-learning diagnostic tools are more likely to flourish in countries outside the United States, Dr. Zhang said. Automated screening systems may be particularly useful in places where doctors are scarce, including in India and China.</p><p>The system built by Dr. Zhang and his colleagues benefited from the large scale of the data set gathered from the hospital in Guangzhou. Similar data sets from American hospitals are typically smaller, both because the average hospital is smaller and because regulations make it difficult to pool data from multiple facilities.</p><p>Dr. Zhang said he and his colleagues were careful to protect patients’ privacy in the new study. But he acknowledged that researchers in China may have an advantage when it comes to collecting and analyzing this kind of data.</p><p>“The sheer size of the population — the sheer size of the data — is a big difference,” he said.</p>

    1 February 12, 2019
  • Basics: Everywhere in the Animal Kingdom, Followers of the Milky Way

    Basics: Everywhere in the Animal Kingdom, Followers of the Milky Way

    sitional variations, they are redefining what used to be a signature characteristic of mammals. </p><p>“It’s the equivalent of giving birth to an 18-year-old,” said Geoffrey Attardo, an entomologist who studies tsetse flies at the University of California, Davis.</p><p>The newborn tsetse fly looks like a hand grenade and moves like a Slinky, and if you squeeze it too hard the source of its plumpness becomes clear — or rather a telltale white. The larva, it seems, is just a big bag of milk. </p><p>“Rupture the gut,” Dr. Attardo said, “and the milk comes spilling out.” </p><p>And milk it truly is — a nutritional, biochemical and immunological designer fluid that the mother fly’s body has spun from her blood meals and pumped into her uterus, where her developing young greedily gulped it down. </p><p>Thus fattened on maternal largess, a tsetse fly larva can safely burrow underground and pupate for 30 days before emerging as a full-blown adult with a nasty bite and a notorious capacity to transmit a deadly disease called sleeping sickness.</p><p>Still other scientists are seeking to tally and understand the compositional differences in the milks from a broad sample of the world’s 5,500 or so mammals. They have unearthed a number of compelling concordances between the demands of oddball mammals and the makeup of their milk.</p><p>Assaying the milk of the nine-banded armadillo, for example, Michael Power, a lactation researcher at the Smithsonian National Zoological Park in Washington, and his colleagues were impressed by the high levels of calcium and phosphorus they detected, and by the even greater concentrations of protein. </p><p>“The protein was through the roof, way above anything else in the milk,” said Dr. Power, co-author with Jay Schulkin of “Milk: The Biology of Lactation.” </p><p>The elevated mineral counts made sense. “What does an armadillo build? A bony shell,” Dr. Power said. “So there’s going to be a lot of calcium and phosphorus going into this baby.” </p><p>But why all the protein? The researchers soon realized it was a matter of chemistry. If you simply dropped large quantities of calcium and phosphorus into most types of mammalian milk, the minerals would glom together into insoluble phosphate compounds. </p><p>“They’d get stuck in the mammary gland and never reach the baby,” Dr. Power said. The solution? Throw in extra doses of casein proteins to bind the minerals into compact, usable nano-clusters. </p><p>“If I’m going to have a high-calcium, high-phosphorus milk, I have to have a high-protein milk,” Dr. Power said, “because a lot of that protein is a calcium-phosphorus delivery device.”</p><p>There was only one way the water isotopes could have ended up in mother’s milk. “She’s lactating in a den,” Dr. Oftedal said. “She’s not eating or drinking. But she is consuming all the excreta of her young, which she then puts back in her milk.” </p><p>Small wonder, then, that the amount of milk the denning mother produced exceeded the weight she lost. “She’s recycling everything,” Dr. Oftedal said.</p><p>Biologists warn against the wanton use of the word milk — sorry, almond “milk” really isn’t — and some mammalogists would like to restrict the term to the secretions of a dedicated mammary gland, which only their study subjects happen to possess. </p><p>But many scientists concur that if a parent synthesizes or highly modifies a substance on which its offspring’s life then depends, that parent is making a milk. By this measure, predigested food alone may not count, but if the parent first adds essential ingredients to the bolus, the regurgitate can fairly be deemed a milk. </p><p>“It’s like kiss-feeding,” Dr. Steiger said. “It looks really nice.” But as the researchers demonstrated, there is more to the osculatory exchange than pulped meat: the parent’s oral fluids are also critical to the young beetle’s survival. </p><p>The researchers have yet to analyze this chocolate-colored beetle milk, but Dr. Steiger suspects that it supplies the larvae with gut microorganisms, antibodies, digestive enzymes and other must-haves for mulching cadavers.</p><p>Wherever it appears, lactation is expensive and demands evolutionary justification. Flamingos are among the few birds that make milk for their young, and the effort drains them of all color — but at least it’s an egalitarian affair. </p><p>A male and female will jointly build a nest, incubate a single large egg and, when the egg hatches, churn out the rich crop milk on which the flamingo chick will feed for nine very long months. Begging calls from the chick stimulate in the parent’s brain the release of prolactin — the same hormone that subserves human lactation — which in turn prompts cells lining the crop, at the base of the parental throat, to swell and secrete the magic formula. </p><p>Brimming with protein and fattier than mammalian milk, flamingo milk “has the consistency of cottage cheese,” said Paul Rose, a flamingo researcher at the University of Exeter in Britain.</p><p>It is also bright pink. The parents spike the milk with the same carotenoid pigments that normally tint a flamingo’s feathers and that happen to be antioxidants — ideal for promoting a chick’s health and rapid growth. </p><p>Weeks and months pass. The parents must steadily step up milk production to meet ballooning demand. By the time the young flamingo is close to full-grown, robust in body and blushing of tone, its parents look thin and depleted, and their once-fuchsia feathers are now winter white. </p><p>“All of their energy, all their pink pigment, has gone into the crop milk,” Dr. Rose said. “Raising a flamingo is a very hard job.”</p><p>What explains the need for such full-throated lactation? Why can’t flamingos simply feed their young on beetles and flies, the way many birds do? Dr. Rose attributes the practice to the flamingo’s exceptional foraging style and the mouthparts necessary to accommodate it. </p><p>Like baleen whales, flamingos are filter feeders, and their distinctively crooked bills act as elaborate sieves. It takes time for a flamingo chick’s straight bill to thicken and bend, and longer still to master the practice of panning for a meal.</p><p>Only in the class Mammalia do all member species nurse their young, yet evolutionary biologists now believe that the roots of mammalian lactation date back more than 300 million years, a good 100 million years before the first mammals appeared. </p><p>The ancestors of modern mammals are thought to have laid the sort of porous, parchment-shelled eggs seen today among lizards, snakes and a couple of weird, monotreme mammals like the platypus. In contrast to the hard-shelled calcified eggs of birds, parchment eggs are at chronic risk of drying out, which means modern snakes and lizards often are constrained by the need to lay their eggs in a relatively damp setting. </p><p>Our ancient forebears stumbled on a liberating solution: Make yourself into a watering can, and you can lay your eggs wherever you want. </p><p>“The likely first function of milk was to hydrate parchment-shelled eggs laid on dry ground,” said Amy Skibiel of the University of Idaho, an expert in mammalian lactation. By this scenario, pre-mammals dribbled fluid onto their eggs through pores on their chest; nipples came much later. </p><p>Hooded seal pups nurse on rapidly shrinking ice floes for just four days, and during that time they manage to double their weight. Not surprisingly, hooded seal milk is more than 60 percent fat — the fattiest milk among mammals. </p><p>It also smells overwhelmingly of fish, as I discovered when I sniff-tested a series of exotic milks at the National Zoo’s world-class milk bank. On the other end of the lipid scale, rhinoceros milk, at 2 percent fat, looks and smells like skim milk. </p><p>Elephant milk is less watery, and I was sure I caught notes of ice cream. Lion’s milk has no discernible odor and, like most carnivore milk, is low in sugars; meat eaters are designed to efficiently wrest their glucose from protein and fat. </p><p>Human milk, by contrast, is extremely sweet. Dr. Skibiel, who tasted her own milk while nursing her baby, said it reminded her of cantaloupe.</p><p>The number and variety of sugars in human milk outstrips that seen in any other great ape, Dr. Power said, and he proposes a surprising reason for that bounty: not to build our big brain, as some have argued, but because we needed sugar’s antimicrobial powers to help us cope with all the novel pathogens we encountered after the agricultural revolution, when we started crowding into villages and living in close quarters with other animals.</p><p>“Our ability to use animals in lots of different ways is one of the reasons we’re successful,” he said, “but it was a huge shock to the system.” Luckily, our milk rose to the challenge. </p><p>“Our brain made our milk,” Dr. Power said, “not the other way around.”</p>

    1 February 12, 2019
  • 
	Miracle treatment or dangerous drug? Indonesian growers cash in on Kratom as it takes hold in the US

    Miracle treatment or dangerous drug? Indonesian growers cash in on Kratom as it takes hold in the US

    e the unlikely ground zero for the global production and export of Kratom, a tree leaf hailed by some as a miracle cure for everything from opioid addiction to anxiety.</p><p>Part of the coffee family, the leaf has been used for centuries in Southeast Asia and Papua New Guinea for its pain-relieving and mildly stimulating effects but it is now sold in powder form and exported worldwide - alarming some health regulators who have raised concerns about safety.</p><p>Kratom stimulates the same brain receptors as morphine, although it produces much milder effects.</p><p>'I take Kratom and have had no problems. Every strain has its benefits - some help you relax, others can treat insomnia or treat drug addiction. Some help increase stamina,' grower Faisal Perdana told AFP.</p><p>Kratom is already banned for domestic consumption though it allows its export in unprocessed form</p><p>Fellow farmer Gusti Prabu, who now exports 10 tonnes of the drug a month, agreed.</p><p>'Our ancestors used Kratom and there were no negative side effects. It can help eliminate drug addiction and help people detox,' he explained.</p><p>But its popularity is causing concern - the drug is unregulated, and has had little clinical testing to assess its safety or side effects.</p><p>Kratom is already banned for domestic consumption in Indonesia, Malaysia and Thailand, though the former allows its export in unprocessed form.</p><p>Health authorities in the United States - now the drug's top importer - have linked consumption of the plant and its derivatives to dozens of deaths, warning it could aggravate a deadly opioid epidemic gripping parts of the country.</p><p>Compounds found in Kratom are opioids, which expose users to the same risks of addiction and death as illicit opiates, according to the US Food and Drug Administration.</p><p>But for farmers in Kapuas Hulu, West Kalimantan - the center of production - demand for Kratom is such that they have moved away from traditional commodities such as rubber and palm oil to start growing the tree, turning it into a major cash crop.</p><p>And at the main post office in Pontianak, the key trading post for this part of Indonesian Borneo, it's clear the health warnings have done little to dampen interest.</p><p>'Around 90 percent of our shipments from West Kalimantan province are Kratom that's been sold to the United States,' post office head Zaenal Hamid said.</p><p>As many as five million Americans use the drug and that number is growing, according to the American Kratom Association.</p><p>Data from 2016 showed that the region was shipping some 400 tonnes abroad every month - worth about $130 million annually at current global prices of some $30 a kilogramme.</p><p>Most Kratom customers are reached through online platforms such as Facebook, Instagram and Chinese e-marketplace Alibaba.</p><p>The trend for alternative medicine has been credited with increasing interest in Kratom from Europe and America, where it is usually consumed as a tea or in capsules.</p><p>The US is struggling with an opioid epidemic, fueled by addiction to prescription painkillers as well as street drugs like heroin and synthetic versions such as fentanyl.</p><p>Kratom is legal in 43 states, but the FDA is pushing for greater restrictions and has already put an import alert on it, which means shipments entering the US can be confiscated.</p><p>In a statement, the organisation warned consumers not to use the drug and said it was 'concerned that Kratom appears to have properties that expose users to the risks of addiction, abuse, and dependence.'</p><p>Scientists say that while Kratom may have positive attributes, very little research has been done into the drug.</p><p>As many as five million Americans use kratom and that number is growing, according to the American Kratom Association</p><p>'It has great potential as a remedy for pain and opioid addiction given its pharmacology and its potential accessibility,' Michael White, head of the department of pharmacy practice at the University of Connecticut, told AFP.</p><p>Advocates insist it's a safe alternative to prescription drugs and can actually help opioid addicts.</p><p>'Of the 44 deaths on record involving Kratom, they all involve poly-drug use,' said Ryan Leung, a spokesman from kratom lobby group Botanical Education Alliance (BEA).</p><p>'The FDA health warnings...(have) proven to be misguided by multiple experts,' he added.</p><p>For now, Indonesian producers are waiting to see how the regulatory battle in the US unfolds.</p><p>And while bad weather and a salmonella scare dented exports in 2017, provisional data showed Kratom shipments bounced back strongly last year.</p><p>Kratom farmer Prabu insisted: 'The Kratom market has been very good over the past decade and it still has potential in the years ahead.'</p><p>He added: 'People will see its usefulness, sooner or later.'</p><p> The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline. </p><p>Do you want to automatically post your MailOnline comments to your Facebook Timeline?</p><p>Your comment will be posted to MailOnline as usual.</p><p>Do you want to automatically post your MailOnline comments to your Facebook Timeline?</p><p> We will automatically post your comment and a link to the news story to your Facebook timeline at the same time it is posted on MailOnline. To do this we will link your MailOnline account with your Facebook account. We’ll ask you to confirm this for your first post to Facebook.</p><p>Part of the Daily Mail, The Mail on Sunday &amp; Metro Media Group</p>

    1 February 09, 2019
  • 
	First US attempt to cure a rare disease with genome editing fails miserably 

    First US attempt to cure a rare disease with genome editing fails miserably 

    a rare disease in the US has returned disappointing results, researchers at Sangamo Therapeutics announced today.</p><p>Gene-editing has been hailed as the best hope to treat inherited disorders. </p><p>Sangamo's trial used proteins that bind to targeted segments of DNA to deliver gene therapy to three patients with a rare genetic disorder that disrupts their ability to process certain sugars, causing damaging build-up in the brain, bones and more. </p><p>But a year and nine months after the trial's start, the patients' levels of harmful sugars have stayed effectively the same, casting a disappointing shadow of doubt over the prospects for 'fixing' the genome. </p><p>Brian Madeux (center, file image) was among the first people to have his genome edited as part of the first US human trial to  attempt to cure two genetic diseases. His genes were successfully edited, but the treatment has so far done little to change markers of the disease, according to preliminary findings of Sangamo Therapeutics trials released today </p><p>More than 6,000 deadly or debilitating diseases lurk in the genetic code. </p><p>Until very recently, all that could be done for people with these diseases was to treat their symptoms - there was no way to cure or reverse these conditions. </p><p>But the theory - and the hope - is that if we can alter the genes that carry these diseases, we could edit mutations out of existence. </p><p>One of the earliest, most promising methods for doing so uses so-called zinc finger nucleases (also referred to as simply zinc fingers, or ZFNs). </p><p>Zinc fingers are a fuse of two compounds that can be engineered to seek out and cut specific segments of DNA. </p><p>The latest advancements for gene-editing use the Nobel Prize-winning CRISPR technology, but the method is too new for human trials.  </p><p>Scientists at Sangamo used these to target genes that code for two related disorders, mucopolysaccharidosis types I and II (MPS I and MPS II). </p><p>MPS I causes Hurler syndrome, a deficiency of an enzyme that, in healthy people, breaks down complex sugar chains called glycosaminoglycans (GAGs). </p><p>In those with Hurler syndrome, GAGs instead build up in the body, becoming toxic and causing symptoms like claw hands, deafness, heart problems, joint and spine abnormalities and worsening mental decline.  </p><p>These children typically have coarse features, enlarged livers and spleens and may have heart and breathing abnormalities. </p><p>MPS II defects cause similar though slightly milder symptoms. Both conditions are more common among boys and affect one in 100,000 to 150,000 births. </p><p>Children with Hurler syndrome, such as this girl pictured in Sangamo's presentation of their findings, tend to have coarse features and as harmful sugar chains build up in their bodies, the compounds become toxic, damaging organs and the brain</p><p>The two diseases are cousins of the rarer, more devastating Sanfilippo syndrome, known as 'childhood Alzheimer's.' </p><p>The best treatment for this family of diseases is enzyme replacement therapy, which can slow declines but is by no means a cure. </p><p>Between its trials for MPS I and II, Sangamo enrolled nine patients who received replacement genes. </p><p>In the technical sense, the experiment worked. The scientists saw that the gene replacement worked and caused minimal side effects. The patients' bodies did begin producing more of the missing enzyme. </p><p>At least two study participants, including Brian Madeux, had their genes successfully changed. </p><p>In earlier reported preliminary results, the study participants' enzyme levels were seeing encouraging increases, and tests of their urine revealed falling levels of GAGs - the most important measure of their diseases. </p><p>In today's results, the patients' GAG levels 'did not show a meaningful change,' and some even increased, said Sangamo CEO, Dr Sandy Macrae on a conference call. </p><p>The replacement DNA 'was permanently integrated into the genome,' a significant step forward, 'but our mission is more  leading the way scientifically,' he added. </p><p>'We are realistic about whether this first generation [treatment] is going to accomplish everything that these patients need it to.' </p><p>One patient struggled during the trial, and it was recommended that they return to the standard enzyme treatment (which most continued to receive though a few withdrew from it and a couple of others are considering doing the same). </p><p>The Sangamo scientists believe that, at higher doses, the therapy may still work, but today's results are inevitably a blow to the hopes of sufferers of rare diseases for whom gene-editing has been an almost singular beacon.   </p><p> The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline. </p><p>Do you want to automatically post your MailOnline comments to your Facebook Timeline?</p><p>Your comment will be posted to MailOnline as usual.</p><p>Do you want to automatically post your MailOnline comments to your Facebook Timeline?</p><p> We will automatically post your comment and a link to the news story to your Facebook timeline at the same time it is posted on MailOnline. To do this we will link your MailOnline account with your Facebook account. We’ll ask you to confirm this for your first post to Facebook.</p><p>Part of the Daily Mail, The Mail on Sunday &amp; Metro Media Group</p>

    1 February 08, 2019
  • 
	Woman, 32, releases graphic photo diary showing 'red raw' skin after ditching eczema steroid creams

    Woman, 32, releases graphic photo diary showing 'red raw' skin after ditching eczema steroid creams

    w' skin in withdrawal after ditching the steroid creams she had been using to treat eczema.</p><p>Larissa Carey, 32, of Portsmouth, Hampshire, had been using the strong medication religiously since her diagnosis at nine months old.</p><p>After noticing the creams weren't working during her adult life, in which stress made her skin dramatically worse, Miss Carey ditched them in January 2018.</p><p>She is believed to have developed topical steroid withdrawal (TSW), a painful skin reaction which occurs in reaction to cutting back on steroid creams.</p><p>Larissa Carey, 32, used steroid creams religiously since her diagnosis at nine months old. Pictured, in December 2017 when she realised they had stopped working</p><p>Weaning herself off the strong medication she had used for life led Miss Carey to develop a little-known condition called topical steroid withdrawal (TSW). Pictured, in March 2018, two months after she stopped using the creams</p><p>Miss Carey, pictured in January, is now on an antibody drug which helped calm her eczema</p><p>Miss Carey still suffers from flare ups, most recently the end of February. She said the only trigger she has found is stress, which became a problem in her adult life</p><p>She said: 'When I stopped using the creams, Robbie and I had just bought our first house together.</p><p>'It should have been this wonderful time, but instead I was bedbound with the pain. I'm only in my 30s, but I felt like I was 100.</p><p>'I knew how important it was to push myself to get out and see people or do things, but I just wanted to hide.</p><p>'I was so worried people would stare, and when it's something like skin that you can't even cover up, it's all the more soul-destroying.'</p><p>Doctors hoped Miss Carey, who has battled eczema for most of her life, would eventually grow out of it.</p><p>One in every five British children are affected by eczema at some stage. But 60 to 70 per cent will have got rid of the condition by their teenage years.</p><p>Miss Carey intermittently used small doses of prescribed steroid creams throughout her childhood.</p><p>'I'd find that sunshine and sea water were a massive help,' Miss Carey said. 'I remember my eczema being particularly bad on my joints and how I'd get told off for scratching in class.</p><p>'But, now I think back, it's nowhere near as severe as dealing with TSW.'</p><p>Instead of easing, Miss Carey's eczema became more severe as an adult, although stress was the only trigger she could identify.</p><p>She said: 'I look back now and try to figure out patterns, examining what was happening in my life at particular points and trying to work out why that'd make it better or worse.</p><p>'The major trigger I found was stress. I tried my best to minimise it in my life, but sometimes, it's out of our control.</p><p>'There is an awful lot of pressure in life now. People are so busy and want to do everything as fast as possible. Then there's also things like social media, and how it makes us compare ourselves to others.</p><p>'They sound like little micro-stresses, but they can all add up without you realising.'</p><p>As her skin condition became more severe, Miss Carey's use of steroid cream increased.</p><p>Miss Carey had been using steroid creams since she was diagnosed with eczema at nine months old. She used them more as she got older when stress was a main trigger for her skin</p><p>Miss Carey said her skin became red raw in the months following her ditch of steroid creams, making it painful even to shower</p><p>Miss Carey said her skin was so sore it was painful to wear underwear. The condition left her bedbound in pain, and she was worried about being judged for her appearance</p><p>By around 2015, she was applying it every few hours, having been told to use it as much as she needed.</p><p>But it appeared that the more she used the less effective it became.</p><p>Miss Carey said: 'You see that word steroid and know it's not something you want to be using every single day.</p><p>Eczema is an inflammatory condition of the skin that leads to redness, blistering, oozing, scaling and thickening.</p><p>It usually appears in the first few months of life and affects around 10 per cent of babies.</p><p>Eczema's cause is not fully understood but it is thought to be brought on by the skin's barrier to the outside world not working properly, which allows irritants and allergy-inducing substances to enter.</p><p>It may be genetic due to the condition often running in families.</p><p>As well as their skin being affected, sufferers may experience insomnia and irritability.</p><p>Many factors can make eczema worse. These may include:</p><p>There is no cure for eczema, however, 70 per cent of childhood sufferers no longer have the condition in their teens.</p><p>Patients should avoid known triggers for flare ups and use emollients.</p><p>'By the end, I was getting no relief whatsoever from the creams.</p><p>'I was still having to bandage my wrists and arms every night to minimise scratching in my sleep, and had to be incredibly careful about what products or materials I put on my skin.</p><p>'I used to love cosmetics, and have this whole vanity case of lovely makeup that I can't use. I could only apply moisturiser to my face, or use prescribed shower gel.' </p><p>At the end of January 2018, Miss Carey decided to ditch the steroid creams for good.</p><p>Miss Carey was completely unprepared for the severe reaction to come.</p><p>By March, her skin – particularly on her face – felt tight, red and raw, as if she had been burned. </p><p>After posting photos to some online eczema support groups for advice, a fellow sufferer mentioned TSW for the first time and, after reading about it, Miss Carey became convinced she had it.</p><p>Many have called the 'condition' a fad, however, it has been recognised by the National Eczema Association since 2013. </p><p>Miss Carey said: 'I contacted some friends that work in medicine and they sent me over some studies to read. The condition is such an unknown, especially as controlled studies are virtually impossible, as they'd mean withholding eczema treatment from somebody who really needs it.</p><p>'But the only change I could think of that had sparked this was coming off the creams.'</p><p>Things continued to go downhill, with Miss Carey's whole body become affected.</p><p>'It got to the point where even showering would leave me in tears, as it was so painful and my skin was so raw I couldn't even wear underwear,' she said.  </p><p>Miss Carey had no choice but to start a course of the immunosuppressant drug cyclosporin which was offered by a dermatologist in April. </p><p>An immunosuppressant drug helped to calm Miss Carey's skin after she saw a dermatologist.</p><p>When she had TSW, Miss Carey's skin felt tight, red and raw, as if she had been burned</p><p>Miss Carey's skin has calmed since she was given an antibody drug called dupilumab </p><p>The antibody drug, pictured, is taken by Miss Carey who also has a hypnotherapist and cognitive behavioural therapist, to deal with the emotional turmoil of her skin condition</p><p>She has also been seeing a naturopath to discuss alternative therapies, as well as a hypnotherapist and cognitive behavioural therapist, to deal with the emotional turmoil.</p><p>Miss Carey said: 'People don't understand, and think it sounds silly to be saying this about a skin condition, but there were genuinely times when I wondered how I was going to get through, if the rest of my life was going to be like this.</p><p>'Everyday things that you take for granted were so difficult, like undressing for a shower. Not only was it painful – I also didn't want to have to look at myself.</p><p>'Thankfully, I am feeling much stronger, though the not knowing why this happened, and living with something so unpredictable is still very tough.'</p><p>Miss Carey has now moved on from taking cyclosporin and is beginning a course of an antibody called duplimab, but still gets flare-ups.</p><p>She is urging doctors to treat eczema patients such as herself holistically, rather than simply prescribing steroid creams.</p><p>In 2015, GPs in England wrote about 27million prescriptions for the topical agents used in the treatment of atopic dermatitis (eczema) at a cost of approximately £169million, according to Allergy UK.</p><p>Miss Carey said: 'There is a time and a place for steroid treatments. Everyone is different and they can help some people, but we also need to be looking at triggers like stress and diet.</p><p>'Every journey is different, and individuals need to do what they can to help themselves.</p><p>'There is, in my mind, a clear link between mental health and skin conditions. Stress is a huge trigger, and you are bound to feel low when there is no end in sight and every little thing you do is a huge decision about whether it'll make your skin better or worse.</p><p>'We are getting better at talking about mental health but we still need to be changing our approach and looking at things as a whole.'</p><p>Topical steroid addiction arises from the use of such creams to treat conditions like eczema. </p><p>First described in 1979 in the International Journal of Dermatology, the theory is, over time, the skin becomes ‘addicted’ to the steroids. But it is not widely accepted among the medical community. </p><p>Many have called the 'condition' a fad, however, it has been recognised by the National Eczema Association since 2013. </p><p>Also known as red skin syndrome, the disorder does not have many statistics to show how common it is. One 2003 study from Japan, found that 12 per cent of adults who were taking steroids to treat dermatitis developed RSS. </p><p>It occurs when steroids have been abruptly discontinued after a prolonged or inappropriate length of administration. Women who blush easily are thought to be most at risk. </p><p>Topical steroid addiction has not been reported with correct drug use.</p><p>Excessive sweating and itching is a sign of recovery.  Many sufferers also develop insomnia. </p><p>Treatment focuses on anxiety support, sleep aids, itch management, infection prevention and immunosuppressants.</p><p>Doctors should advise patients to avoid long term or high dose steroid use. Long term is considered to be one-to-two years of regular use.</p><p>Patients are also advised to cut down on steroids slowly but using a lower dose and gradually cutting back to, for example, every other day or a few times a week. </p><p>Do you want to automatically post your MailOnline comments to your Facebook Timeline?</p><p>Your comment will be posted to MailOnline as usual.</p><p>Do you want to automatically post your MailOnline comments to your Facebook Timeline?</p><p> We will automatically post your comment and a link to the news story to your Facebook timeline at the same time it is posted on MailOnline. To do this we will link your MailOnline account with your Facebook account. We’ll ask you to confirm this for your first post to Facebook.</p><p>Part of the Daily Mail, The Mail on Sunday &amp; Metro Media Group</p>

    1 February 07, 2019

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