First drug approved to treat rare metabolic disorder

(HealthDay)—The U.S. Food and Drug Administration approved the first treatment for the rare genetic disorder primary hyperoxaluria type 1 (PH1), the agency announced Monday.

Oxlumo (lumasiran) is approved to treat PH1, the most common and most severe type of primary hyperoxalurias, which can lead to progressive kidney damage and eventually damage to other organs. One to three individuals per million in North America and Europe are believed to be affected by PH1.

The approval of Oxlumo was based on data from two studies. In the first study, a randomized, placebo-controlled trial, 26 patients aged 6 years and older received a monthly injection of Oxlumo followed by a maintenance dose every three months, while 13 patients received placebo injections. Patients who received Oxlumo had an average 68 percent reduction of oxalate in the urine compared with a 12 percent reduction for patients who received placebo. After six months, 52 percent of patients treated with Oxlumo versus none who received placebo reached a normal 24-hour urinary oxalate level. The second study was an open-label study of 16 patients all younger than 6 years who received Oxlumo. Data showed an average 71 percent decrease in oxalate in the urine after six months.

The most commonly reported side effects of Oxlumo include injection site reaction and abdominal pain.

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DR MICHAEL MOSLEY: Why won't the NHS tell you how to treat diabetes?

DR MICHAEL MOSLEY: Why won’t the NHS tell you the secret to treating diabetes? (Clue: It costs nothing)

Eight years ago I managed to beat type 2 diabetes by going on my 5:2 diet (cutting my calories two days a week) and losing weight — 9kg to be precise. 

Since then I’ve become something of a broken record on the importance of shedding body fat to improve your blood sugar levels.

So I was delighted last week by the news from the Norfolk Diabetes Prevention Study — the largest of its kind in the world — which showed that even modest weight loss can have a big impact.

A recent review by Danish researchers found more than 70 per cent of people with type 2 diabetes who had lost significant amounts of weight were still medication-free more than five years later [File photo]

The Norfolk study recruited more than 1,000 people with pre-diabetes (meaning they had raised blood sugar levels). They were asked to lose weight, then were monitored for more than eight years. Those who managed to lose 2kg to 3kg, and keep it off, almost halved their risk of developing full-blown type 2.

This adds to extensive research carried out by British scientists showing that, as well as pre-diabetes, type 2 diabetes can be put into remission by going on a rapid weight-loss diet. And, as we’ve known for 20 years, weight-loss surgery can also reverse type 2.

In fact, a recent review by Danish researchers found more than 70 per cent of people with type 2 diabetes who had lost significant amounts of weight were still medication-free more than five years later.

Despite all this, the NHS Choices website still tells you type 2 diabetes is a ‘progressive’ disease that ‘usually gets worse over time’, with most people needing ever increasing levels of medication. What a depressing — and I would argue inaccurate — message.

So why aren’t they being a bit more encouraging? The situation with type 2 diabetes reminds me of a tussle I had with the medical establishment more than 25 years ago. 

In 1993 I was looking around for a subject to make a science documentary, when I came across the work of two Australians, Dr Barry Marshall and Dr Robin Warren, who had a striking new theory about stomach ulcers.

I was delighted last week by the news from the Norfolk Diabetes Prevention Study — the largest of its kind in the world — which showed that even modest weight loss can have a big impact [File photo]

At the time, stomach or duodenal ulcers (affecting the first part of the small intestine) were incredibly common but, like type 2, were seen as something of a mystery.

Gut ulcers can be excruciatingly painful and lead to internal bleeding. Doctors knew they were caused by excess acid and they could be managed by drugs such as ranitidine, which stopped the stomach from producing acid. These drugs, known as proton pump inhibitors, were expensive but there was a lot of incentive to use them because if you didn’t, or if the drugs stopped working, there was a high chance you’d need some of your stomach and intestines removed.

Robin and Barry, however, were convinced they had a cheap and effective cure. Their research showed that most patients with ulcers were infected with a bacterium, which the two doctors called Helicobacter pylori.

The patients’ stomachs were producing more acid to get rid of the bacterium, but this failed because Helicobacter is resistant to acid attack. But it is vulnerable to the right antibiotics.

To prove the point, Barry deliberately infected himself with Helicobacter (he swallowed a flask of it) and soon developed gastritis — massive inflammation — which he cured with a short course of antibiotics. This was in 1984.

Nine years later, when I began filming with Robin and Barry, there was still widespread resistance to their claims, despite extensive proof they were right.

When I asked Barry how long he thought it would take to persuade his colleagues to take their claims seriously, he laconically replied, ‘Well it’s been ten years and ten per cent of doctors are treating ulcers this way. Perhaps in 100 years they will all be doing it.’

In fact, within ten years almost all doctors were doing it. Not least because Barry and Robin won the Nobel Prize for Medicine in 2004 for their work.

But back in 1994, when my documentary, Ulcer Wars, detailing their work, came out, the medical reaction was either indifference or hostility. A review in The British Medical Journal by a leading gastroenterologist described the film as ‘one sided and tendentious’.

However, patients with duodenal ulcers who’d watched the programme soon began demanding antibiotic treatment.

Many later wrote to me and as one man put it: ‘I saw your programme a week before I was due to have surgery, and it was only because my doctor was prepared to listen that I was cured by antibiotics rather than having a chunk of my guts removed.’

Why did it take so long for doctors to adopt this approach, despite overwhelming evidence that eradicating Helicobacter could change patients’ lives? This was a question that researchers from Harvard asked in 2019 — concluding that it was mainly because doctors get much of their information from pharmaceutical companies, and these companies had no incentive to promote a cheap alternative to their acid-reducing drugs (which, of course, you took for life).

The parallels with type 2 diabetes are clear. As the millions of those affected in the UK will know, type 2 is usually treated with medication. 

While this will reduce the long-term damage caused by high blood sugar levels, it doesn’t deal with the underlying disease — and like all medication, the drugs can have significant side-effects, particularly when you move on to injecting insulin.

So how long before there’s widespread acceptance that most cases of type 2 diabetes can be put into remission by a rapid weight-loss diet? 

It is beginning to happen, but I wouldn’t guarantee that NHS Choices will be telling you the good news any time soon.

Like us, worms need to sleep. And the way their bodies prepare for sleep is also surprisingly similar to humans — one of the key triggers for a bit of shut eye is the release of melatonin, also known as the ‘hormone of darkness’.

Melatonin is produced in your brain and levels rise when it gets dark (synthetic melatonin is a popular sleep aid and is used to treat jet lag — I find it very effective).Now researchers at the University of Connecticut have discovered how melatonin actually works — in worms at least.

It slows the release of neurotransmitters, substances that allow messages to travel between nerve cells. So melatonin effectively tells your brain cells to stop chatting to each other — the chemical equivalent of a giant ‘shhh’!

Covid-19 vaccines are like buses; you wait for one, then two come along, almost together, with other contenders coming close behind.

This week we learnt that the vaccine made by Moderna may be even more effective than Pfizer’s. That both are more than 90 per cent effective is fantastic news and a real poke in the eye for the sceptics who claimed we might never get a vaccine against Covid-19, let alone several.

These findings also suggest that our immune system is doing what evolution designed it to do: mount a strong response to the virus.

There was a fear that Covid-19 might mutate into a more resistant form — or that our immune response might weaken. 

Yet recent research suggests that while antibody levels tend to fall over time, your immune system retains a ‘memory’ of the virus. So if you encounter it again, your body is ready to begin churning out antibodies and T-killer cells.

Which makes me wonder why Boris, who’s had Covid, is self-isolating. He’s unlikely to be ‘bursting with antibodies’ as he claims, but he’s also very unlikely to get it again, or to be infectious, so I can’t see how he’s a threat to others. 

Our immune system has been severely tested by Covid, but as the new vaccines show, it just needs a bit of help to get back on top.

Covid-19 vaccines are like buses; you wait for one, then two come along, almost together, with other contenders coming close behind [File photo]

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Cannabis to treat gynecological conditions

A significant number of women would consider using cannabis to treat gynecological conditions, primarily gynecological pain. Women with a history of cannabis use are reported in a study in Journal of Women’s Health.

Women who self-medicate with cannabis do so to relieve chronic pelvic pain, menstrual cramps, and pain associated with gynecological cancer or medical procedures such as abortion.

“A larger proportion of women who reported ever using cannabis were willing to use cannabis to treat conditions commonly seen in gynecological practices compared to never-users (91.6% vs. 64.6%),” states Leo Han, MD, MPH, and coauthors, from Oregon Health & Science University. This difference was statistically significant.

“Coinciding with the increased perception of cannabis safety is the increased national recognition of the dangers of opioid pain medications,” says the authors.

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Study reinforces drug’s potential to treat hypertrophic cardiomyopathy

Research at Washington State University sheds new light on one molecule that may be used to treat a heart condition that can lead to stroke, heart attack and other forms of heart disease.

That molecule is mavacamten. Scientists at WSU’s Integrative Physiology and Neuroscience department discovered it suppresses excessive force generated by hyper-contractile muscle cells in the human heart.

The research, published in the British Journal of Pharmacology, is especially significant for those with hypertrophic cardiomyopathy, a genetic condition where the left ventricle wall of the heart is enlarged. If left untreated, hypertrophic cardiomyopathy can lead to cardiac fibrosis, stroke, heart attack, heart failure, other forms of heart disease and a condition known as sudden arrhythmic death syndrome.

“Too much contraction leads to thicker, stiffer hearts, where the heart contracts so much it is unable to properly fill with blood as the heart relaxes,” said Peter Awinda, first author on the paper and scientific manager in Bertrand Tanner’s laboratory at WSU. “This ends up pushing less blood out of the heart with each heartbeat and, in turn, less blood pumped throughout the body like it is supposed to be.”

Hypertrophic cardiomyopathy affects men and women equally. About 1 out of every 500 people have the disease.While there are some genetic markers to detect it, most people only discover their condition after a cardiac event that often results in a hospital visit.

The research

The project is a collaboration between the Tanner Laboratory in Pullman and Ken Campbell’s laboratory at University of Kentucky. Campbell manages a human cardiac biobank, where he ships tissue samples frozen in liquid nitrogen to Tanner, who is the principal investigator for the research.

After arriving in Pullman, the cardiac tissue was thawed, ‘skinned’ to remove the cell membrane, and trimmed to the right dimensions for an experiment.

Three micrograms of the drug, mavacamten, were then applied to some of the prepared tissue samples; other samples did not receive the drug and were labeled as controls.

To activate muscle contraction Awinda applied calcium to the tissue.

“As we increase calcium concentration it encourages contraction and the muscle goes from relaxed to contracted, and so we were testing the drug against these different levels of force,” Awinda said.

He found the drug reduces the maximal force of contraction by nearly 20 to 30% compared to the controls.

“The drug is successful because it is an inhibitor of myosin, which is one of the proteins required for the muscle contraction process,” Awinda said. “The research shows this could be a good candidate to treat hypertrophic cardiomyopathy.”

The collaborative study was made possible by organ donors and their families. The work was paid for by a $300,000 grant from the American Heart Association to Tanner and Campbell.

These initial studies helped Tanner and Campbell add an additional $2.8 million grant from the National Institutes of Health to support additional work in this area over the next 4 years.

Next steps

One of the research team’s next goals is to see how mice with a human mutation for hypertrophic cardiomyopathy respond to the drug.

Awinda said researching mice expressing the human gene is significant because it may provide a connection to what is seen in humans.

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Researchers advance drug delivery systems to treat connective tissue disorders

University of Delaware Professor Kristi Kiick is leading collaborative research to create new drug delivery systems with the potential to improve treatment for diseases that affect connective tissues, such as osteoarthritis or rheumatoid arthritis, which is an autoimmune disease.

The UD researchers have devised tiny cargo-carrying systems many times smaller than a human hair. These systems, or carriers, are made from molecules called peptides that help provide structure for cells and tissues.

The research team is working to program these nanoparticle carriers to selectively bind to degrading collagen in the body. Collagen is a protein that helps plump up or provide structure to connective tissue—everything from our skin to our bones, tendons and ligaments.

When collagen degrades, as a result of disease or injury, the nanoparticles designed by the Kiick lab can attach and remain at the injury site longer than many current treatment options. This allows for the possibility of delivering site-specific medicines over longer periods of time—from days to weeks.

In one collaborative project that involves this work, Kiick is trying to develop drug carriers that could be useful in treating osteoarthritis. Osteoarthritis is a degenerative joint disorder characterized by inflammation, pain and stiffness. According to the Centers for Disease Control and Prevention, it affects 32.5 million Americans.

Early studies with Christopher Price, an associate professor in biomedical engineering, suggests that these nanoparticles can be retained in tissue and knee joints. In other related studies, Kiick and her students have shown that drugs can be encapsulated and retained in the nanoparticles, until released by changes in temperature.

“We are interested in learning how to release drugs that can help not just with pain management, but also with slowing down disease progression,” said Kiick, Blue and Gold Distinguished Professor of Materials Science and Engineering. “It has been key that we have been able to collaborate with the Price laboratory in this type of work.”

For a long time, small molecule corticosteroids have been a standard of care for managing pain in osteoarthritic joints. Because the joint is full of thick, sticky fluid and is under constant mechanical stress and motion, these small-molecule drugs get expelled from the fluid around the knee pretty quickly, in minutes.

“We are hopeful that by controlling the nanoparticle composition and structure,” said Kiick, “we will be able to finely control, or tune, the drug delivery behavior to provide longer-lasting relief for people with inflammatory conditions, such as osteoarthritis.”

Kiick and colleagues reported advances on the nanoparticle design on Wednesday, Oct. 7, in a paper published in Science Advances, a peer-reviewed journal of the American Association for the Advancement of Science. Co-authors on the work include Jingya Qia, a graduate student in the Kiick lab, and Jennifer Sloppy, a senior microscopy specialist in UD’s Harker Interdisciplinary Science and Engineering Laboratory.

The paper’s key findings demonstrate the research team’s ability to control the shape of the nanoparticles, which will impact how well they can bind to tissue in the body and stay in a particular location. The research team also can precisely control the size of the nanoparticles, which has implications for how they might be retained at the injection site and also how they may be used by particular cells before being removed from the body. Finally, the paper describes some of the very fine details of how the specific building blocks inside these peptide molecules can affect the temperature at which those different shaped and sized nanoparticles can be disassembled to release a medicine.

The research builds on Kiick’s previous patented and patent-pending work in this area, but she said it is collaboration with others that is driving forward promising results. While the Kiick lab brings expertise in creating novel materials that can be used as delivery systems; Arthi Jayaraman, Centennial Term Professor for Excellence in Research and Education in the Department of Chemical and Biomolecular Engineering, is helping the team understand factors related to temperature sensitivity of the delivery vehicles and to develop computational tools that can help the research team characterize the vehicle’s shape.

Meanwhile, Price’s expertise in understanding post-traumatic osteoarthritis has been key to developing methods to use these nanoparticles to potentially treat disease. Price is exploring how particular drugs and cells interact, which may inform what specific classes of medicines are useful in treating osteoarthritis that develops following traumatic injury. The collaboration will help the Kiick lab tailor what types of nanoparticle devices can be used to deliver these different classes of medicines.

According to Kiick, thinking big, the team could imagine loading a custom cocktail of medicines into the drug-delivering nanoparticles capable of delivering relief over varying timescales and temperatures. The researchers already have the right material nanostructure that can allow this to happen; now they are exploring how to trigger the nanoparticles to release specific medications under particular conditions.

“You could imagine injecting these encapsulated medications at the knee,” she explained. “Then, when you want one medication to be released, the patient could ice their knee. If another drug is needed to provide relief over a longer time-period, heat could be applied.”

It could be a really simple way to help people manage chronic conditions that cause a lot of pain and reduce mobility. And because the treatment is local, it could reduce side effects that can occur when drugs have to be taken at high doses or over prolonged periods of time.

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AI to better diagnose and treat renal cancer and COVID-19

USC researchers are using AI to fuel more confident diagnosis of renal tumors, as well as more customized treatment for cancer patients and patients infected with COVID-19.

Kidney cancer is among the 10 most common cancers. In 2019, the American Cancer Society estimated 73,820 new cases of kidney cancer and 14,770 deaths from this disease. The five-year survival rate reduces from 93% in low-risk groups to 69% in high risk groups of patients with localized kidney cancer. However, following the spread of cancer, these rates plummet to 12%.

For radiologists, a fundamental driver of diagnosing renal cancer remains visual and qualitative, meaning CT scans (images of a mass) are largely evaluated based on individual knowledge and experience. To improve accuracy, this visual analysis has been supplemented by quantitative assessment of renal masses through radiomics, the extraction of quantifiable characteristics from the images.

Researchers at the University of Southern California, including Vinay Duddalwar, director of the USC Radiomics Laboratory and Professor of Clinical Radiology, Urology and Biomedical Engineering at the Keck School of Medicine of USC, and Assad Oberai, Hughes Professor in the Department of Aerospace and Mechanical Engineering and Interim Vice Dean for Research at the USC Viterbi School of Engineering, are combining deep learning with existing contrast CT scanning to help radiologists make more confident diagnoses. Their research was published in the British Journal of Radiology.

The widespread use of contrast enhanced CT, where an intravenous contrast agent like a dye is injected into the tumor and imaged over four distinct points in time, has led to the increased detection of kidney cancers that would have otherwise remained undetected. While many of the tumors identified this way can be labeled benign fairly easily, a significant portion prove more complicated, requiring further invasive testing, the researchers said. Such testing might include biopsies, which might also be inconclusive, pushing many patients to prefer going straight to surgery to remove the tumor in case it is malignant.

“Using a purely visual qualification, 20-25% of all tumors taken out in the U.S. today in the range of 3-5 cm are benign, and didn’t need to come out,” Duddalwar said.

Oberai and Duddalwar recognized this process could be improved by better utilizing existing data. “We wanted to combine what Assad’s group does in deep learning with what my group does in radiomics to improve accuracy of diagnosis,” Duddalwar said.

The researchers also hope such advances could help better understand individual patients’ prognosis in dealing with renal cancer, as well as in addressing diseases such as COVID-19, where individuals report widely varied reactions to infection and treatment.

The research team also includes: from the Keck School of Medicine Associate Professor of Clinical Pathology Manju Aron, Associate Professor of Research Neurology Steven Cen, Executive Director of the USC Institute of Urology Inderbir Gill, medical student researcher at the Department of Radiology Christopher Lau and Assistant Professor in Research Radiology Bino Varghese; and from USC Viterbi computer science student Tomas Angelini and Assistant Professor of Research Radiology and Biomedical Engineering Darryl Hwang.

Contrast Enhanced CT Scans Used to Identify Variations in Tumors

Contrast enhanced CT scans can help diagnose specific cancers, like renal cancer, because of the changes in vascularity seen in such cancers. In a usual workflow, Duddalwar’s group would look at the images of a tumor taken at four different points in time: pre-injection of the contrast agent, 30-40 seconds after injection, 80-90 seconds after injection and then about five minutes after injection. The contrast agent helps identify characteristics related to vascularity, for example, how much blood supply is flowing through the tumor. How early the tumor enhances and washes out compared to the rest of the kidney can help indicate what sort of tumor the patient might have, the researchers said.

“Imagine if you’re sitting at the bank of a river and someone injects a dye further upriver. If the dye gets to where you are quickly, then you know that the current is moving faster. If the dyes spread out, then you know that the flow is turbulent. So you can say a lot about the flow by observing what happens to the dye. Think of the vascular system in the same way. It’s a closed loop fluid system, so if you inject a fluid somewhere, you can watch for it somewhere else,” Oberai said.”For example, if you inject the dye into a blood vessel, but do not observe it downstream, you might be dealing with a tumor that is blocking the vessel and thwarting the flow of blood.”

How the dye diffuses through tissue reveals a lot about the underlying pathophysiology and can help determine a more accurate diagnosis. Instead of recommending more tests and procedures, the deep learning algorithm relies on data collected in the four contrast CT scans. “We are not doing any extra imaging,” Duddalwar said. “We’re using the images already collected and then evaluating them in a different way, so it is no extra expense to the patient or to the healthcare system.” In this way, images collected have the opportunity to convey more data to experts than previously accessible.

Building on Quantitative Evaluations in Radiomics

Radiomics computations can take three to four people about 30-40 minutes to produce results on one patient’s CT scans. An AI algorithm working with the same data can produce results in a matter of seconds.

But efficiency isn’t the most important factor, Oberai said. “More than the time, it’s the effort of experts trying to subjectively figure out where the tumor is, where the boundary is and get the correct margins. What we want to do is save experts’ time for more important tasks, such as evaluating other images and studies, conducting research and teaching and ultimately contributing to improved clinical care through optimized workflow.”

Incorporating deep learning can also help identify new markers that might not otherwise have been discovered. Said Duddalwar: “When you utilize radiomics, you pre-judge, by choosing which element(s) (for example uniformity or asymmetry) you want to evaluate. But with deep learning, you make no such assumption. You let the algorithm figure out what the important characteristic is going to be, which might be an element you never imagined would be significant to diagnosis.”

In the study, the deep learning algorithm demonstrated a 78% accuracy rate in diagnosing the most challenging scans, a rate on par with results produced using radiomics.

Integrating Patient History with Imaging Data

Next the researchers hope to integrate information about a patient’s medical history and clinical examination to help not only improve the accuracy of a diagnosis, but also an individual’s prognosis in treatment.

“We’re looking at using all the imaging information and combining it with clinical data (patient health history, blood tests, symptomology) to make an even more accurate prediction,” Oberai said. “It’s about more than just giving an answer about whether the tumor is benign or malignant, but also producing a number based on all the informational and image inputs that shares how confident the algorithm is about its results.”

He added: “Additionally, we want to be able to have a dynamic model, which can be updated as newer information comes in. For example, a cancer patient might be scanned every three months. We want to see the model updated based on newer data and help better understand the trajectory of the illness for each individual.”

The researchers are looking to apply this beyond diagnosis of renal cancer to its treatment. “We’re trying to find potential markers to help us identify the best treatment straight away instead of wasting months on trial and error,” Duddalwar said. “At the same time, we want to see if deep learning algorithms can help identify which tumors have a better versus worse prognosis for our patients.”

One of the more urgent adaptations the researchers are pursuing is how to leverage this work to better diagnose and treat COVID-19. “Putting together patient symptomology and clinical data with images, you can get a more accurate sense not just of diagnosis but of prognosis. In the case of COVID-19, the data collected can help the model predict how the patient might do—not just whether or not they will recover or get sicker, but also whether or not the patient will need to go to the ICU or require a ventilator.”

The group is going to look at data from COVID-19 patients initially from the USC Health Science campus, which includes the LA County Medical Center. Their research group includes other radiologists, epidemiologists and biostatisticians.

The coronavirus behaves differently in varying locations due to a variety of factors, which are difficult for doctors to access and apply during treatment. However, an algorithm trained on such data can bring in these disparate factors and help link everything together, the researchers said.

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Singer Amy Grant Just Had Open Heart Surgery To Treat A Rare Condition Called PAPVR

  • Christian singer Amy Grant had open heart surgery to treat a rare heart condition.
  • She was recently diagnosed with partial anomalous pulmonary venous return (PAPVR).
  • Because PAPVR is a congenital abnormality, Amy has had this condition since birth.

Singer Amy Grant shared some surprising news with fans this week: She just underwent open heart surgery to correct a rare heart condition called partial anomalous pulmonary venous return (PAPVR) that she’s had since birth.

“Thank you for all the prayers today! Amy’s heart surgery went well and she is recovering in the care of a great team of doctors. More updates to come,” a rep for Amy wrote in a post shared on Amy’s Instagram account on Thursday.

https://www.instagram.com/p/CA_7aHTDzcQ/

The “Every Heartbeat” singer had heart surgery on Wednesday to fix her rare heart condition PAPVR, which her doctor discovered earlier this year, People reported.

PAPVR is a congenital abnormality (meaning someone is born with it) where some of the pulmonary veins connect to the right atrium of the heart. This can cause blood that’s rich in oxygen to flow back to the lungs, instead of to the rest of the body, according to University of Wisconsin-Madison Health’s website. That can lead to symptoms like shortness of breath during heavy exercise.

“She had open heart surgery to correct a condition from birth the doctors discovered during a heart checkup called PAPVR,” Amy’s publicist told People. “Thankfully the doctor said it could not have gone better.”

Amy first shared news of her condition back in February in a statement on Twitter. At the time, she said that her doctor recommended she have her heart health checked out due to her family history. After a “battery of tests,” she was given a diagnosis that she didn’t share at the time. Amy also said at the time that she was “completely asymptomatic” and that her condition was “fixable.” “Instead of concerts and camping trips this summer, I am going to take care of my heart,” she wrote.

Fans were given a heads up on Facebook earlier this week that the surgery would be happening. “With all that is going on in our world that needs our collective prayer, please also join us in praying for Amy this week as she has heart surgery to correct her PAPVR condition,” her team wrote on Facebook.

Treatment for PAPVR is surgery under general anesthesia which, it seems, Amy had. During the surgery, the surgeon cuts open the patient’s breastbone and exposes the heart, according to UW Health. Blood from the heart is redirected to a bypass machine, while the doctor redirects blood flow from the anomalous pulmonary vein to the left atrium. Then, the bypass machine is shut down and the heart starts beating again.

Amy’s publicist told People that her team is “praying for a full and easy recovery over the next days, weeks, and months to come.”

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There’s no evidence chloroquine helps treat or prevent COVID-19

In new Practice Points, the American College of Physicians (ACP) says that evidence does not support the use of chloroquine or hydroxychloroquine alone or in combination with azithromycin to prevent COVID-19 after infection with novel coronavirus (SARS-CoV-2), or for treatment of patients with COVID-19. The ACP Practice Points also state that physicians, in light of known harms and very uncertain evidence of benefit, may choose to treat the hospitalized COVID-19 positive patients with chloroquine or hydroxychloroquine alone or in combination with azithromycin in the context of a clinical trial using shared and informed decision-making with patients and their families. “Should Clinicians Use Chloroquine or Hydroxychloroquine Alone or In Combination with Azithromycin for the Prophylaxis or Treatment of COVID-19? Living Practice Points from the American College of Physicians (Version 1)” was published today in Annals of Internal Medicine.

The ACP Practice Points provide rapid clinical advice based on a concise summary of the best available evidence on the benefits and harms of the use of chloroquine or hydroxychloroquine alone or in combination with azithromycin for the prophylaxis or treatment of COVID-19. The Practice Points are based on a rapid systematic review conducted by the University of Connecticut Health Outcomes, Policy, and Evidence Synthesis Group.

ACP Practice Points are developed by ACP’s Scientific Medical Policy Committee and provide advice to improve the health of individuals and populations and promote high value care based on the best available evidence derived from assessment of scientific work (e.g. clinical guidelines, systematic reviews, individual studies). ACP Practice Points aim to address the value of screening and diagnostic tests and therapeutic interventions for various diseases, and consider known determinants of health, including but not limited to genetic variability, environment, and lifestyle.

“With the rapid emergence of COVID-19, physicians and clinicians have found themselves managing the frontlines of the pandemic with a paucity of evidence available to inform treatment decisions,” said Jacqueline W. Fincher, MD, MACP, president, ACP. “ACP rapidly developed its Practice Points as concise, synthesized summaries of the current state of evidence in order to address urgent questions related to the transmission, diagnosis, and treatment of COVID-19. As such, these Practice Points give frontline physicians guidance to provide patients with the care based on the best available evidence.”

Chloroquine and hydroxychloroquine are used to manage other major ailments with a known benefit and are in short supply in the United States. These medications also have known harms in non-COVID patients such as cardiovascular effects; diarrhea; abnormal liver function; rash; headache; ocular issues; and anemia.

Using chloroquine or hydroxychloroquine, with or without azithromycin, to prevent or treat COVID-19 infection began to receive attention following preliminary reports from in vitro and human studies. While several studies are planned or underway, the Practice Points provide details about the lack of and/or insufficient current research about the benefits and harms for prevention and treatment of COVID-19.

At this time, the authors of the Practice Points have identified that chloroquine or hydroxychloroquine alone or in combination with azithromycin to prevent COVID-19 after infection with novel coronavirus (SARS-CoV-2), or for treatment of patients with COVID-19 should not be used. The Practice Points also state that the drugs may only be used to treat hospitalized COVID-19 positive patients in the context of a clinical trial following shared and informed decision-making between clinicians and patients (and their families) that includes a discussion of known harms of chloroquine and hydroxychloroquine and very uncertain evidence of benefit for COVID-19 patients.

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