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Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Monday, July 13, 2015

Ebola Nearly Claimed His Life, Then It Hid in His Eye

Satellite image of Sierra Leone
Satellite image of Sierra Leone (Photo credit: Wikipedia)
BY DENISE GRADY


ATLANTA - When Dr. Ian Crozier was released from Emory University Hospital in October after a long, brutal fight with Ebola that nearly ended his life, his medical team thought he was cured. But less than two months later, he was back at the hospital with fading sight, intense pain and soaring pressure in his left eye.

Test results were chilling: The inside of Dr. Crozier’s eye was teeming with Ebola.

His doctors were amazed. Months had passed since he became ill while working in an Ebola treatment ward in Sierra Leone as a volunteer for the World Health Organization. By the time he left Emory, his blood was Ebola-free.

Almost nothing was known about the ability of Ebola to lurk inside the eye, but despite the infection, Dr. Crozier’s tears and the surface of his eye were virus-free, so he posed no risk to anyone who had casual contact with him.

More than a year after the epidemic in West Africa was recognized, doctors are still learning about Ebola and Lingering effects on survivors. Now, however, with at least 10,000 survivors in Guinea, Liberia and Sierra Leone, patterns are emerging.

Dr. Crozier, 44, calls himself a poster child for “post-Ebola syndrome.” Besides eye trouble, he has had debilitating joint and muscle pain, deep fatigue and hearing loss.

At ELWA Hospital in Monrovia, Liberia, run by the missionary group SIM, Dr.John Fankhauser, the medical director, said such ailments were the most common physical problems among the hundred or so people attending a special clinic for Ebola survivors.

In Sierra Leone, the picture is much the same, according to Dr. John S. Schieffelin, a physician from the Tulane University School of Medicine in New Orleans who volunteered there. He said a well-organized survivor group met regularly in Kenema.

“The main problems they’re telling me about are lots of body and joint pains, chronic headaches and women who stopped having menstrual periods, and for some it’s been several months,” Dr. Schieffelin said.” There’s quite a bit of vision problems.”

The inside of the eye is mostly shielded from the immune system to prevent vision damage. The barriers are not fully understood, but they include tightly packed cells in minute blood vessels that keep out certain cells, along with unique biological properties that inhibit the immune system. But this “immune privilege” can sometimes turn the inner eye into a sanctuary for viruses.

The question was whether Dr. Crozier’s sight could be saved. Severe inflammation suggested that the barriers that normally protect the eye from the immune system had been breached. So what was damaging Dr. Crozier’s eye? The virus, the inflammation or both?

The usual treatment for inflammation is steroids. But they can make an infection worse.

“What if it unleashed the virus?” Dr. Crozier said. “We were on a tightrope.”

Though Dr. Crozier was the patient, he was also part of his own medical team, and his focus on the scientific details helped counter his mounting fear that he was going blind. As he and his physicians struggled to balance treating the inflammation with fighting the infection, his eyesight continued to deteriorate.

He also had significant hearing loss on the same side. “The whole left side of your life is gone, “he said. “It was a very dark and depressing time.”

The biggest shock came when he glanced in the mirror one morning and saw that his eye color had changed from bright blue to a vivid green.

“It was like an assault,” he said. “It was so personal.”

Dr. Jay Varkey, an infectious-disease specialist who had handled much of Dr. Crozier’s care, got special permission from the United States Food and Drug Administration to use an experimental antiviral drug taken in pill form. (The doctors declined to name it.)

At first, there seemed to be no effect. But a week or so later, Dr. Crozier realized that if he turned his head this way and that, he could find “portals” through the obstructions in his eye.

His sight returned in a few months, and his eye turned blue again.

Was it the antiviral drug? He cannot be sure, but he think so.

Dr. Varkey said, “I think the cure was Ian’s own immune system.” He said he suspected the treatments had reduced Dr. Crozier’s symptoms and helped preserve his sight long enough for his immune system to kick in and clear out the virus-just as supportive care during the worst phase of his initial illness had kept him alive until his natural defenses could take over.

Dr. Crozier believes information from his case may help prevent blindness in Ebola survivors in West Africa. In April, he headed to Liberia with Dr. Steven Yeh, an ophthalmologist, and several other Emory physicians to see patients who had recovered from Ebola and examine their eyes.

“Maybe we can change the natural history of the disease for survivors,” Dr. Crozier said. “I want to start that conversation.”


Taken from TODAY Saturday Edition, The New York Times International Weekly, May 23, 2015

Wednesday, January 4, 2012

US approves first heart pump for children

A new hope... for kids!
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Posted: 18 December 2011


A model of a heart
WASHINGTON: The US Food and Drug Administration has approved a first mechanical cardiac assist device for children that can help keep patients alive as they await a transplant.

The EXCOR Pediatric System, made by German company Berlin Heart, can be sized to fit young people from newborns to teenagers.

"This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," said Susan Cummins, chief pediatric medical officer in the FDA's Center for Devices and Radiological Health.

"Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart," she added in a statement Friday.

The device was tested on a group of 48 US patients, and was found to improve survival rates for transplant patients compared with the use of extracorporeal membrane oxygenation, the current standard of care, though not FDA approved.

As a whole, a reported 12-17 percent of children and 23 percent of infants die while they await heart transplants, according to the FDA.

- AFP/cc



Taken from ChannelNewsAsia.com; source article is below:
US approves first heart pump for children

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Wednesday, June 15, 2011

Implant breakthrough helps paraplegic man stand unaided

Now, this IS something!
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Posted: 20 May 2011


Hit-an- run victim Rob Summers, a paraplegic, being moved into position on a treadmill. (AFP Source: AFP)
PARIS - In a world first, neurosurgeons in the US said on Friday electrodes implanted in the lower spine had enabled a paraplegic man to stand up unaided, move his legs voluntarily and, with help, walk on a treadmill.

The therapy marks an exciting advance in the quest to overcome crippling injuries of the spinal cord, they said.

"This is a breakthrough," said Susan Harkema, a professor at the Spinal Cord Research Center at the University of Louisville, Kentucky, who led the 11-member team.

"It opens up a huge opportunity to improve the daily functioning of these individuals...but we have a long road ahead."

The work, published online by The Lancet, was carried out on a young volunteer, now aged 25, who had been completely paralysed below the chest after a tragic hit-and-run accident in 2006.

Today, after 26 months of retraining of the leg muscles, followed by the pioneering surgery, the patient can reach a standing position and support his own weight for up to four minutes at a time.

Helped by a harness support and some assistance from a therapist, he can make repeated stepping motions on a treadmill. He can also voluntarily move his toes, ankles, knees and hips on command.

The patient, Rob Summers, said he was ecstatic.

"This procedure has completely changed my life," he said.

"For someone who for four years was unable to even move a toe, to have the freedom and ability to stand on my own is the most amazing feeling."

"To be able to pick up my foot and step down again was unbelievable, but beyond all of that, my sense of wellbeing has changed. My physique and muscle tone has improved greatly, so much that most people don't even believe I am paralysed."

Paralysis comes from damage to the spinal cord down which the brain sends electrical signals along nerve fibres to instruct limb movement.

The research focuses on nerve networks in the lower spine that are relatively autonomous -- they can follow through the commands for weight-bearing and coordinated stepping without input from the brain.

The mechanism works thanks to feedback from nerves in the muscles of the legs and feet that is sent directly to the spinal cord.

It is this sensory input that helps the individual to adjust his balance and speed of movement and level of weight-bearing in response to surfaces and inclines.

"The spinal cord can independently interpret these data and send movement instructions back to the legs -- all without cortical 1/8 cerebral 3/8 involvement," explained Reggie Edgerton, a professor of integrative biology and comparative physiology at the University of California, Los Angeles.

The technique entailed giving Summers 26 months of locomotor training to get his leg muscles used again to the sensation of movement, thus reviving the feedback system.

Surgeons then implanted 16 electrodes in the lumbosacral spinal cord, connecting them to thick nerve bundles that largely control movement of the ankles, hips, knees and toes.

The unit then sends down electrical signals to mimic those sent down the spine by the brain in order to initiate movement.

With Summers, electrostimulation was part of sessions lasting up to 250 minutes.

The success has fired hopes that at least some individuals with spinal paralysis can use a portable stimulation unit to trigger the movements needed to stand up and bear weight.

With the help of a walker, it is hoped, such patients would maintain balance and execute some effective stepping.

There could be even greater secondary benefits, including perhaps the restoration of bladder and sphincter control and sexual response.

But only one person has so far had the treatment, out of five authorised by the US Food and Drug Administration (FDA).

Summers, while completely paralysed below the chest, was rated a "B" on the US classification of spinal injury, as he did retain some feeling below the spot where the damage occurred.

So it is unknown whether the procedure will work on "A" patients, who have no sensation below the injury. In addition, Summers is young and was extremely fit before his accident.

Drugs are being developed to heighten the sensitivity and function of the spinal cord neural network, which could further enhance the technique.

-AFP/rt


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Taken from ChannelNewsAsia.com; source article is below:
Implant breakthrough helps paraplegic man stand unaided

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