Successful Transplant of Porcine Heart into Adult Human

In a first-of-its-kind surgery, a 57-year-old patient with terminal heart disease received a successful transplant of a genetically-modified pig heart and is still doing well three days later. It was the only currently available option for the patient. The historic surgery was conducted by University of Maryland School of Medicine (UMSOM) faculty at the University of Maryland Medical Center (UMMC), together known as the University of Maryland Medicine.

This organ transplant demonstrated for the first time that a genetically-modified animal heart can function like a human heart without immediate rejection by the body. The patient, David Bennett, a Maryland resident, is being carefully monitored over the next days and weeks to determine whether the transplant provides lifesaving benefits. He had been deemed ineligible for a conventional heart transplant at UMMC as well as at several other leading transplant centers that reviewed his medical records.

 “It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice,” said Mr. Bennett, the patient, a day before the surgery was conducted. He had been hospitalized and bedridden for the past few months.  I look forward to getting out of bed after I recover.

The U.S. Food and Drug Administration granted emergency authorization for the surgery on New Year’s Eve through its expanded access (compassionate use) provision. It is used when an experimental medical product, in this case the genetically-modified pig’s heart, is the only option available for a patient faced with a serious or life-threatening medical condition. The authorization to proceed was granted in the hope of saving the patient’s life.

“This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients,” said Bartley P. Griffith, MD, who surgically transplanted the pig heart into the patient. Dr. Griffith is the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at UMSOM. “We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.”

Considered one of the world’s foremost experts on transplanting animal organs, known as xenotransplantation, Muhammad M. Mohiuddin, MD, Professor of Surgery at UMSOM, joined the UMSOM faculty five years ago and established the Cardiac Xenotransplantation Program with Dr. Griffith. Dr. Mohiuddin serves as the program’s Scientific/Program Director and Dr. Griffith as its Clinical Director.

“This is the culmination of years of highly complicated research to hone this technique in animals with survival times that have reached beyond nine months. The FDA used our data and data on the experimental pig to authorize the transplant in an end-stage heart disease patient who had no other treatment options,” said Dr. Mohiuddin.The successful procedure provided valuable information to help the medical community improve this potentially life-saving method in future patients.

Source: https://www.medschool.umaryland.edu/

Neuralink Founder Elon Musk Says It Can ‘Safely’ Start Implanting Its Brain Chips In Humans By 2022

Elon Musk said Neuralink, a brain-interface technology company he co-founded, is hoping to start implanting its microchips in humans next year. In a live broadcast interview at The Wall Street Journal CEO Council Summit on Monday, Musk announced that Neuralink hopes to start implanting chips in 2022. Musk went on to say that they’ve been testing Neuralink in monkeys and confirmed that it’s ‘very safe and reliable. He also clarified that the Neuralink brain chip can easily be removed.

We hope to have this in our first humans – which will be people that have severe spinal cord injuries like tetraplegics, quadriplegics – next year, pending FDA approval,” Musk said.

According to him, Neuralink has substantially higher standards than what the FDA usually requires when implanting the chips. In 2019, Musk hoped to begin human trials by late 2020, but it got delayed. Earlier this year, in February, he said Neuralink would start implanting the chip in people by the end of 2021. This time, it seems Musk is overly confident that the trials will certainly kick off in 2022.

Meanwhile, another brain-interface company, Synchron, will also start its human trials in July 2022 and have already been approved by the FDA.

Source: https://www.techtimes.com/

Pfizer CEO: “Very High Level of Confidence” that the Covid Treatment Pill Is Effective Against the Omicron Variant

Pfizer CEO Albert Bourla said he expects the company’s Covid-19 treatment pill to be effective against the omicron variant of the virus causes Covid-19.

The good news when it comes to our treatment, it was designed with that in mind, it was designed with the fact that most mutations are coming in the spikes,” Bourla explained.  “So that gives me very high level of confidence that the treatment will not be affected, our oral treatment will not be affected by this virus.”

Pfizer submitted its application earlier this month to the Food and Drug Administration (FDA) to authorize the pill, Paxlovid, for emergency use. In a clinical trial of people age 18 and over, Pfizer found the pill reduces hospitalization and death by 89% when taken with a widely used HIV drug within three days of the start of symptoms. The pill blocks an enzyme the virus needs to replicate. It is used in combination with HIV drug ritonavir, which slows the human metabolism to allow the Paxlovid to remain active in the body longer at a higher concentration to combat the virus.

https://www.cnbc.com/

Virtual Reality System to Ease Back Pain

A 3-D virtual reality system to treat back pain was approved by the U.S. Food and Drug Administration (FDA) this week. The EaseVRx system is a prescription device for at-home use that combines cognitive behavioral therapy and other behavioral methods to treat patients 18 and older with chronic lower back pain.

Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Dr. Christopher Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA‘s Center for Devices and Radiological Health.

Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain,” Loftus said in an agency news release.

A treatment program includes 56 VR sessions that are 2 to 16 minutes long as part of a daily eight-week treatment program. The FDA approval is based on a clinical trial that included 179 patients with chronic lower back pain assigned to one of two eight-week VR programs: the EaseVRx 3-D program or a control 2-D program that did not feature CBT methods.

At the end of treatment, 66% of EaseVRx participants reported a greater than 30% reduction in pain, compared to 41% of those in the control groupA greater than 50% pain reduction was reported by 46% of the EaseVRx users, compared with 26% of those in the control group, according to the FDA.

One, two and three months after treatment, all EaseVRx users still reported a 30% reduction in pain, which was higher than in the control group. Nearly 21% of EaseVRx users reported discomfort with the headset and about 10% reported motion sickness and nausea, but there were no serious side effects associated with the system, which is made by AppliedVR.

Source:  https://www.upi.com/

FDA-approved Drugs Slow or Reverse Alzheimer’s

A research team at Washington University School of Medicine in St. Louis has identified potential new treatment targets for Alzheimer’s disease, as well as existing drugs that have therapeutic potential against these targets.

The potential targets are defective proteins that lead to the buildup of amyloid in the brain, contributing to the onset of problems with memory and thinking that are the hallmark of Alzheimer’s. The 15 existing drugs identified by the researchers have been approved by the Food and Drug Administration (FDA) for other purposes, providing the possibility of clinical trials that could begin sooner than is typical, according to the researchers.

In addition, the experiments yielded seven drugs that may be useful for treating faulty proteins linked to Parkinson’s disease, six for stroke and one for amyotrophic lateral sclerosis (ALS).

Scientists have worked for decades to develop treatments for Alzheimer’s by targeting genes rooted in the disease process but have had little success. That approach has led to several dead ends because many of those genes don’t fundamentally alter proteins at work in the brain. The new study takes a different approach, by focusing on proteins in the brain, and other tissues, whose function has been altered.

In this study, we used human samples and the latest technologies to better understand the biology of Alzheimer’s disease,” said principal investigator Carlos Cruchaga, the Reuben Morriss III Professor of Neurology and a professor of psychiatry. “Using Alzheimer’s disease samples, we’ve been able to identify new genes, druggable targets and FDA-approved compounds that interact with those targets to potentially slow or reverse the progress of Alzheimer’s.”

The scientists focused on protein levels in the brain, cerebrospinal fluid (CSF) and blood plasma of people with and without Alzheimer’s disease. Some of the proteins were made by genes previously linked to Alzheimer’s risk, while others were made by genes not previously connected to the disease. After identifying the proteins, the researchers compared their results to several databases of existing drugs that affect those proteins.

The new study, funded by the National Institute on Aging of the National Institutes of Health (NIH), is published in the journal Nature Neuroscience.

Source: https://source.wustl.edu/

Anti-diabetic Medication at a Specific Dosage Makes you Loose Weight

A weight-loss drug described as a ‘game-changer by obesity researchers has just been approved by the US Food and Drug Administration (FDA), representing the first time the agency has endorsed such a treatment in several years. Wegovy, a weight-management therapy to be manufactured by Danish pharmaceutical company Novo Nordisk, is the the first FDA-approved weight-loss drug since 2014, but it’s not entirely a new medication.

The same drug, called semaglutide, has been used in the US and other countries as an anti-diabetic medication for years. More recently, however, evidence has shown that semaglutide at a different dosage also functions as a powerful and effective appetite-suppressant. In a study published earlier in the year involving almost 2,000 obese adults from 16 different countries, researchers reported that long-term treatment with the medicine led to almost 15 percent weight loss on average across the cohort.

Some lost even more, with over 30 percent of the group dropping in excess of 20 percent of their body weight – results that the scientists singled out as remarkable.

No other drug has come close to producing this level of weight loss – this really is a game-changer,” obesity researcher Rachel Batterham from University College London said at the time.

For the first time, people can achieve through drugs what was only possible through weight-loss surgery.”

Source: https://www.sciencealert.com/

F.D.A. Approves Alzheimer’s Drug

Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s not enough evidence it can address cognitive symptomsThe Food and Drug Administration  approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.

The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms. Biogen, its manufacturer, announced that the list price would be $56,000 a year. In addition, there will most likely be tens of thousands of dollars in costs for diagnostic testing and brain imaging. Recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval for the drug to be used but required Biogen to conduct a new clinical trial. If the new trial, called a Phase 4 trial, fails to show the drug is effective, the F.D.A. can — but is not required to — rescind its approval.

About six million people in the United States and roughly 30 million globally have Alzheimer’s, a number expected to double by 2050. Currently, five medications approved in the United States can delay cognitive decline for several months in various Alzheimer’s stages. Patient advocacy groups had lobbied vigorously for approval because there are so few treatments available for the debilitating condition. Some other drugs in clinical trials are more promising, but they are most likely three or four years away from potential approval.

The F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. They also said that even if it could slow cognitive decline in some patients, the benefit suggested by the evidence would be so slight that it would not outweigh the risk of swelling or bleeding in the brain that the drug caused in the trials.

The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit,” the F.D.A.’s director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, wrote on the agency’s website. But, she said, the agency had decided to approve the drug through a program called accelerated approval, which is designed “to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.” Michel Vounatsos, Biogen’s chief executive, hailed the approval and said in a statement, “We are committed to sharing our future insights about Aduhelm with the scientific community as we collect more data from the real-world use of this treatment.

Source: https://www.nytimes.com/

How to Completely Wipe out Colon Cancer in Anybody Who Gets Screened

Michael Wallace has performed hundreds of colonoscopies in his 20 years as a gastroenterologist. He thinks he’s pretty good at recognizing the growths, or polyps, that can spring up along the ridges of the colon and potentially turn into cancer. But he isn’t always perfect. Sometimes the polyps are flat and hard to see. Other times, doctors just miss them. “We’re all humans,” says Wallace, who works at the Mayo Clinic. After a morning of back-to-back procedures that require attention to minute details, he says, “we get tired.”

Colonoscopies, if unpleasant, are highly effective at sussing out pre-cancerous polyps and preventing colon cancer. But the effectiveness of the procedure rests heavily on the abilities of the physician performing it. Now, the Food and Drug Administration has approved a new tool that promises to help doctors recognize precancerous growths during a colonoscopy: an artificial intelligence system made by Medtronic. Doctors say that alongside other measures, the tool could help improve diagnoses.

 

We really have the opportunity to completely wipe out colon cancer in anybody who gets screened,” says Wallace, who consulted with Medtronic on the project.

The Medtronic system, called GI Genius, has seen the inside of more colons than most doctors. Medtronic and partner Cosmo Pharmaceuticals trained the algorithm to recognize polyps by reviewing more than 13 million videos of colonoscopies conducted in Europe and the US that Cosmo had collected while running drug trials. To “teach” the AI to distinguish potentially dangerous growths, the images were labeled by gastroenterologists as either normal or unhealthy tissue. Then the AI was tested on progressively harder-to-recognize polyps, starting with colonoscopies that were performed under perfect conditions and moving to more difficult challenges, like distinguishing a polyp that was very small, only in range of the camera briefly, or hidden in a dark spot. The system, which can be added to the scopes that doctors already use to perform a colonoscopy, follows along as the doctor probes the colon, highlighting potential polyps with a green box. GI Genius was approved in Europe in October 2019 and is the first AI cleared by the FDA for helping detect colorectal polyps. “It found things that even I missed,” says Wallace, who co-authored the first validation study of GI Genius. “It’s an impressive system.”

Source: https://www.wired.com/

Johnson & Johnson One-Shot Coronavirus Vaccine Approved in the U.S.

A Centers for Disease Control advisory panel on Sunday recommended Johnson & Johnson’s one-shot COVID-19 vaccine for people 18 and over, clearing the way for inoculations to begin as soon as this week. The recommendation comes one day after the Food and Drug Administration (FDA) on Saturday authorized Johnson & Johnson‘s COVID-19 vaccine for emergency use.

The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said Saturday.

The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The vaccine is the third to be approved for use in the U.S., and the first that requires only one shot. The FDA‘s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend authorizing the vaccine by Janssen, a division of Johnson & Johnson, on Friday. The committee provides expert advice to the FDA, but does not have final say on approval.

https://www.cbsnews.com/

Amazon is now selling COVID-19 tests for customers to use at home

The DxTerity COVID-19 Saliva at-Home Collection Kit detects the presence of the virus but does not confirm immunity or detect antibodies. DxTerity‘s molecular-based PCR test received approval from the Food and Drug Administration last month. The test differs from the quicker and less expensive antigen tests, which use a nasal swab or throat swab to detect the virus.

A single COVID-19 testing kit is listed for $110, and a 10-pack bundle is available for $1,000.

Test takers must spit into a tube provided by the kit. The saliva sample is then inserted into a plastic bag and packed back into the box for shipment to one of DxTerity‘s laboratories certified by the Clinical Laboratory Improvement Amendments. Customers are also granted prepaid express return shipping with the test and should expect to receive results within 24 to 72 hours of sample receipt at the laboratory. DxTerity’s test is currently the only COVID-19 testing kit on Amazon.

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We have demonstrated the reliability and quality of our COVID-19 testing solution with big business and now we want to expand access to customers at home and small businesses,” said Bob Terbrueggen, founder and CEO of DxTerity, when he first announced the collaboration with the company last month. “Amazon is the perfect partner for expanding access to millions of U.S. customers.”

The test may not be valid for all travel purposes because sample collection is unsupervised, according to the product description. The Centers for Disease Control and Prevention recommends saliva specimens should be collected under supervision.

Amazon joins other retail giants in offering at-home COVID-19 saliva tests. Costco offers both regular and those approved for travel requirements to Hawaii, Bermuda and some other destinations for $129.99 and $139.99, respectively. However, the test has several dozen one-star reviews, with most complaining about delayed shipping and poor customer service from provider AZOVA.

Source: https://eu.usatoday.com/