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From The Editors Health

Researchers Develop ‘Brain Decoder’ That Can Translate Unspoken Thoughts into Speech

A team of researchers led by Dr. Edward Chang at the University of California in San Francisco has developed a ‘brain decoder’ – a kind of mind-reading device that effectively translates your neural activity into recognizable speech, 75% of the time.

The study entitled ‘Speech synthesis from neural decoding of spoken sentences,’ published Wednesday (April 24) in the journal Nature, involved five epileptic volunteers, including four women and one man awaiting neurosurgery for their condition.

The patients had temporary electrodes implanted on their brain surface as a pre-surgery procedure to help identify and map the areas of the brain responsible for their affliction.

For the study, additional sensors were attached to the lips, tongue, and teeth to monitor their movements as the volunteers were made to read out hundreds of sentences, mostly passages from children’s classics like Sleeping Beauty, Alice in Wonderland, and The Frog Prince.

Electrical activity in the brains related to their vocal tract movement during the reading exercise was decoded and fed to a specially programmed computer system to produce intelligible sentences.

In humans, the vocal tract comprises the oral cavity, which includes the lips, inner cheeks, tongue, upper and lower gums, floor and roof of the mouth, and the small area behind the wisdom teeth, in addition to the nasal cavity, larynx, and the pharynx – all of which work in near-perfect harmony to produce intelligible sentences when we talk.

Dr. Chang’s team was able to equate the neural signals responsible for the movement of each of the vocal tract components with the participants’ speech.

The decoded neural activity was then converted into synthesized language with the help of a neural network linked to a voice synthesizer.

“Recurrent neural networks first decoded directly recorded cortical activity into representations of articulatory movement, and then transformed these representations into speech acoustics,” wrote the authors of the study.

To put it as simply as possible, it was, basically, a two-step process that involved translating neural activity into vocal movements and then transforming those movements into speech.

Although the reproduced speech sounds pretty much, well, synthetic, it is remarkably intelligible.

Also, considering that this is just the beginning, we can expect to see enhanced speech quality as the technology is further researched and fine-tuned in times to come.

This brief video clip will let you know exactly what we’re talking about here.

What’s amazing is that not only did the breakthrough decoder transform sentences that were read aloud, but it was also able to translate silently mimed sentences into audible speech.

In order to determine the recognizability of the decoded speech, hundreds of volunteers were asked to listen to 101 synthesized sentences and transcribe what they heard.

The results – as varied as they turned out to be – were nevertheless encouraging enough to warrant further research of the technology, as it has the potential to improve the quality of life of hundreds of thousands of people suffering from speech impairment due to conditions such as paralysis, ALS (amyotrophic lateral sclerosis ), throat cancer and Parkinson’s disease.

“Of the 101 synthesized trials, at least one listener was able to provide a perfect transcription for 82 sentences with a 25-word pool and 60 sentences with a 50-word pool,” wrote the authors, adding that the findings “may be an important next step in realizing speech restoration for patients with paralysis.”

Conventional speech-synthesizing technology in use today involves interpreting how speech sounds are represented in the brains – a tedious, time-consuming process that, at best, translates about eight words per minute; far slower than the 100-150 words per minute that natural speech is capable of.

The new technology has the potential to overcome these limitations and make near-normal conversation a reality, hopefully, in the not too distant future.

Dr. Chang’s team followed a different route, targeting those areas of the brain that send signals to the various vocal tract components, discussed earlier, in order for them to move in perfect unison, thereby enabling speech.

“For the first time … we can generate entire spoken sentences based on an individual’s brain activity,” said Chang.

“This is an exhilarating proof of principle that, with technology that is already within reach, we should be able to build a device that is clinically viable in patients with speech loss,” added the lead author of the paper.

Kate Watkins, a cognitive neuroscience professor at the University of Oxford, was quoted by The Guardian as saying that the research was a “huge advance” that could prove to be “really important for providing people who have no means of producing language with a device that could deliver that for them.”

“The brain is the most efficient machine that has evolved over millennia, and speech is one of the hallmarks of behavior of humans that sets us apart from even all the non-human primates,” Gopala Anumanchipalli, one of the co-authors of the study. was quoted by National Geographic as saying.

“And we take it for granted—we don’t even realize how complex this motor behavior is,” Anumanchipalli said.

In an accompanying News and Views article in the journal Nature, Yahia H. Ali and Chethan Pandarinath from Emory University, Atlanta, US, have expressed hope that continued research will go a long way in helping people with speech issues “regain the ability to freely speak their minds and reconnect with the world around them.”

While there’s still a lot of work left to be done before the technology can be perfected, it’s good to know that we’re headed in the right direction.

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From The Editors Health

New Breath-Based Test to Detect Multiple Cancer Types – Currently Under Clinical Trial

Doctors at the Cancer Research UK Cambridge Institute have, apparently, made a revolutionary medical breakthrough by devising a ten-minute breath biopsy for the early detection of several types of cancer.

Developed by study sponsor, Owlstone Medical, a British company specializing in breath-based clinical diagnostics and precision medicine, the breathalyzer is currently undergoing a clinical trial called “PAN Cancer Trial for Early Detection of Cancer in Breath.”

“Owlstone Medical will be funding the trial directly, however, none of this would be possible without the support and infrastructure provided by Cancer Research UK,” the company said in a statement.

Led by Prof. Rebecca Fitzgerald – MRC Programme Leader at the MRC Cancer Unit and an Honorary Consultant in Gastroenterology and General Medicine at Addenbrooke’s Hospital, Cambridge – the trial proposes to involve some 1,500 volunteers by 2021, including healthy controls.

The non-invasive breath-biopsy device is designed to detect volatile organic compounds, or VOCs, present in a person’s exhaled breath.

Cells produce a range of VOCs during the body’s natural metabolic processes, each of which has a distinctive signature.

When cells become cancerous, VOC signatures are likely to undergo changes, which is exactly what the researchers are hoping to detect using the new test.

“The PAN trial is seeing if you can use a breath test device that detects volatile molecules from the breath to identify patients that might have an early cancer that they don’t know about,” Prof. Fitzgerald said.

Writing in a Cancer Research UK blog, Prof. Fitzgerald said that the pilot study would initially attempt to detect signatures for a range of cancers and identify anomalies by comparing them to healthy individuals.

“Intuitively, lung cancer seems the most obvious cancer to be detected in the breath, but because of the way metabolites are recycled in the body, many other volatile molecules from other areas of the body end up in the breath too,” she wrote.

Over the course of the clinical trial, Prof. Fitzgerald and Owlstone researchers will be looking for distinctive biomarkers in the exhaled molecules of, both, healthy participants as well as those with suspected oesophageal, stomach, kidney, bladder, liver, pancreatic, or prostate cancer.

Once the team is able to differentiate between healthy and cancerous VOC signatures, they will next try and identify differences between cancer types – unless all cancer signatures are one and the same.

“There is increasing potential for breath-based tests to aid diagnosis, sitting alongside blood and urine tests in an effort to help doctors detect and treat disease,” Owlstone co-founder and CEO Billy Boyle said in a statement.

“The concept of providing a whole-body snapshot in a completely non-invasive way is very powerful and could reduce harm by sparing patients from more invasive tests that they don’t need,” Boyle added.

Owlstone-developed breathalyzers, part of the company’s Breath Biopsy® platform, uses a “proven microchip chemical sensor technology (FAIMS) to detect biomarkers of disease” so that they can analyze VOCs present in exhaled breath, says the company website.

Not only does the platform have an application in cancer, but a “wide range of other medical conditions,” as well.

“Highly sensitive and selective, these tests allow for early diagnosis when treatments are more effective and more lives can be saved,” the website goes on to claim.

Prof. Fitzgerald herself has been suffering from a condition called Barrett’s esophagus for the last twenty years and undergoes an endoscopy once every two years to make sure things are under control.

Records show that one to five percent of all Barrett’s esophagus patients eventually end up with oesophageal cancer.

“I’m used to endoscopies by now, you just have to get on with them,” said the 54-year-old researcher.

“But they can be painful and invasive, so when I have one I choose to be sedated,” she said, adding that “the procedure means a whole day out and it takes quite a while to recover afterwards.”

With first-hand experience of the painfully invasive procedure, who else can better understand the benefits of an effective non-invasive diagnostic test than Prof. Fitzgerald, and that is the reason why she has volunteered to be among the first to participate in the clinical trial.

“Something like a breath test sounds so much better than what I have to have, so I was very happy to do the trial,” she said.

“After the breath test I felt fine, it was a very easy and there was no discomfort,” she continued.

“The more these conditions can be researched, and kinder detection tests developed, the better,” she added.

“This study will be the first step towards evaluating VOCs analysis as a test to improve early detection rates for cancer with future applicability to primary care,” says the study paper, published on ClinicalTrials.gov.

“Ultimately, such a research program could enable low cost and widespread targeted screening programs for cancer,” it adds.

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From The Editors Health

Scientists Invent Wearable Testicle-Chiller to Enhance Fertility in Men

If you found the idea of Autoblow AI – the world’s first oral sex device for men – disgusting, here’s one that will put a smile on your face, or even make you laugh out loud.

Scientists have come up with a wearable testicle refrigerator, of sorts, that not only keeps the unmentionables in their place but also boosts their sperm-producing capabilities by keeping them a degree or two cooler than the body temperature.

Of course, the latter is what the inventors have designed the device for; the former is just a bonus benefit.

My apologies if I have offended anyone by using the term “unmentionables” to describe them, as I do understand that there are many who mention these guys at the drop of a hat, and what’s more is that they have different nicknames for these hanging marvels.

Jokes apart, if CoolMen can truly boost sperm count as its developers claim, it could well prove to be the world’s best non-invasive fertility-boosting option for all those fatherhood aspirants out there.

Developed by Cooltec Limited, a Polish company that claims to specialize in helping men “becoming fathers,” the contraption consists of two rubber-lined pouches, shaped precisely to give the testicles a snug fit, and a waistband that is attached to the two holders.

CoolMen is worn like underwear and supposed to be kept on for at least 12-16 hours every day for three to four weeks to derive maximum benefit out of it.

Testicles work best when they’re a degree or two cooler than the body temperature
Testicles work best when they’re a degree or two cooler than the body temperature

The materials used in manufacturing CoolMen are flexible and lightweight to avoid injury and to make the device as comfortable as possible, considering it is meant to be kept strapped on for extended periods of time.

Male infertility has been on the rise in recent times, largely due to unhealthy lifestyles, such as eating habits, lack of exercise, smoking, excessive indulgence in alcoholic beverages, and the likes.

Low sperm count can also result from regular use of tight-fitting clothes, too many saunas, driving or cycling regularly for long hours and, of course, conditions like obesity and diabetes, to name a couple.

However, Cooltec says that reduced sperm count, or infertility, is “most commonly associated with elevated testicular temperatures,” which should ideally be one to two degrees Celsius below the normal body temperature.

“Elevated temperatures result in the death of cells from which spermatozoa are formed and further stages of the spermatogenesis process,” says the company website.

“Because of this, the quality of the semen from superheated testicles decreases,” the website goes on to add.

The company claims that CoolMen can also be used to effectively treat varicoceles, a scrotal condition that also causes infertility, affecting as many as fifteen to twenty percent of all men, with a higher vulnerability rate among older men.

Embedded sensors in the pouches constantly monitor the temperature of the testicles and feed the data to a dedicated smartphone app allowing for real-time readings.

The wearer can share the stored data with his doctor who can then work out a suitable line of treatment.

CoolMen smartphone app.
CoolMen smartphone app.

By the way, CoolMen can also record the wearer’s steps, calorie intake and heart rate, which makes it almost as good as a smartwatch and worth the $305 price tag attached to it.

If only it could read the time as well, but then smartwatches can’t read the temperature of your testicles, can they?

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From The Editors Health

Electric Bandage Can Speed Up Healing Process in Skin Wounds, New Study Reveals

Medical practitioners have long known that electric stimulations can act as an effective catalyst in the healing process of skin wounds, but practical applications have been elusive and largely limited to “clumsy” electrical systems.

Although skin is largely self-healing, skin wound recovery in many cases is painfully slow, literally – even non-existent in some people.

In the United States only, more than 6.5 million people suffer from non-healing skin wounds, including diabetic foot ulcers, venous-related ulcerations, and some surgical wounds, all of which can lead to long-term suffering, both mental and physical.

Doctors have tried a variety of treatments, including bandaging, dressing, exposure to oxygen and growth-factor therapy to help heal chronic skin wounds, but have had limited success with all of those approaches.

The good news is that a team of Chinese and U.S. scientists may have found just the ideal solution to the longstanding problem in the form of an electric bandage.

Researchers at the University of Wisconsin (Madison, Wisconsin, USA), University of Electronic Science and Technology of China (Chengdu, China) and Huazhong University of Science and Technology (Wuhan, China) were able to develop an electrical bandage (e-bandage) that considerably sped up the healing of wounds in rats.

A nanogenerator built into the bandage converts “mechanical displacement from skin movements into electricity,” thereby generating “an alternating discrete electric field,” which can stimulate the skin wound into healing four times faster than regular treatments, at least in rats.

“Rat studies demonstrated rapid closure of a full-thickness rectangular skin wound within 3 days as compared to 12 days of usual contraction-based healing processes in rodents,” wrote the authors of the study, published in the journal ACS Nano.

“From in vitro studies, the accelerated skin wound healing was attributed to electric field-facilitated fibroblast migration, proliferation, and transdifferentiation,” say the authors.

“This self-powered electric-dressing modality could lead to a facile therapeutic strategy for nonhealing skin wound treatment.”

Known for its therapeutic value for centuries, electricity has been used by healthcare professionals in treating a variety of conditions, ranging from neurological diseases to brain disorders like insanity; from pain management to shoulder and other musculoskeletal disorders, to name a few.

In fact, electrotherapy dates as far back as 1743 when it was first used by German physician and naturalist Johann Gottlob Krüger, who, along with compatriot Christian Gottlieb Kratzenstein, is considered the founder of modern electrotherapy.

18th-century English cleric and theologian John Wesley advocated electrical therapy as a cure-all for all afflictions, which was rejected outright by the mainstream medical community.

Italian physicist, Giovanni Aldini used static electricity for treating insanity in the 1820s.

However, it was British medical doctor Golding Bird at Guy’s Hospital in Southwark in central London who was responsible for bringing electrotherapy into mainstream medicine in the mid-1800s.

Over the years, many electrical contraptions, including some cruel ones, have been used to administer electric treatment to patients.

One such apparatus was the 19th-century “electric bath,” which was used to build up high-voltage electric charge on patients’ bodies.

Here are some more crazy contraptions used in electrotherapy by the quacks of yesteryears.

  • The Oudin coil – also known as the Oudin oscillator or Oudin resonator, was a high-voltage induction coil used by quacks for electrotherapy around the turn of the 20th century.
  • Pulvermacher’s chain – a wearable electrochemical device mostly used by quacks in the second half of the 19th century.
  • Leyden jars – an early form of capacitor, for storing electricity
  • Electrostatic generators of various sorts (Source: Wikipedia)
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From The Editors Health Top 5

Top Five Health Stories of 2018

Uber Launched UBER HEALTH – New Ride-Hailing Platform for Non-Emergency Patients

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Uber may have played its part in addressing transportation issues across sections of society, but it hadn’t paid much attention to what the company itself acknowledged was “vital to all of us: health.”

However, in March this year, the ride-hailing company launched ‘Uber Health’ – a HIPAA-compliant platform, tailored to suit the healthcare industry.

HIPAA (Health Insurance Portability and Accountability Act) was signed by President Bill Clinton in 1996 to safeguard the privacy and security of patients’ health-related information and data.

Uber Health is planned along the lines of UberCENTRAL, a service that allows the company’s business customers to provide transportation to their clients.

According to healthcare statistics, at least 3.6 million non-emergency patients in the country fail to turn up for their medical appointments because of the lack of dependable transportation options.

The concept behind the platform is to partner with healthcare providers, including hospitals, clinics, rehabilitation centers, senior care facilities, home care centers, and the likes, in order to allow them access to the “Uber Health” dashboard for ordering rides on behalf of patients, to and from their appointment.

Additionally, the company has introduced a platform-specific API (application programming interface) to allow smooth integrations of Uber Health into existing healthcare products.

Uber Health bypasses the need for an Uber app, or even a smartphone for that matter, considering the fact that there are many patients out there who do not own smartphones or those who find apps a bit too complicated to understand.

Uber Health allows partners to book rides on behalf of patients through the Uber Health dashboard and text them the trip details, or call them on their mobiles or landlines with the information, thereby taking apps and smartphones out of the equation

FDA Ordered Recall of Carcinogen-Contaminated Blood Pressure & Heart Medicines

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In July, the US Food and Drug Administration (FDA) issued an alert to healthcare professionals and patients for a voluntary recall of several brands of drugs that were found to contain NDMA-contaminated Valsartan.

Valsartan is generally used by healthcare professionals to treat high blood pressure and heart conditions in patients.

Some of the companies selling these Valsartan-based drugs, which go by different brand names, are marketing products whose Valsartan content doesn’t meet the US Food and Drug Administration’s safety requirements.

The sub-standard Valsartan has been found to contain a dangerous impurity, referred to as NDMA, short for N-nitrosodimethylamine – a substance believed to be “a probable human carcinogen (a substance that could cause cancer).

FDA attributed the Valsartan contamination to deviations from the standard manufacturing practice for the drug.

The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb said in the July 13 press release.

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” Gottlieb said, justifying the recall.

The FDA alert came in the wake of a multi-nation recall that saw 22 countries recalling some 2,300 batches of Valsartan-containing drugs, just a week prior to the FDA press release.

In November, the FDA recalled another common blood pressure medicine, Irbesartan, manufactured by ScieGen Pharmaceuticals.

The US Federal Drug Administration said ScieGen Pharmaceuticals was recalling certain batches of Irbesartan tablets because they contained an organic chemical called N-nitrosodiethylamine (NDEA), classified by the International Agency for Research on Cancer as a possible human carcinogen.

According to the FDA, NDEA “occurs naturally in certain foods, drinking water, air pollution, and industrial processes.”

FDA Approved Swedish Birth Control App ‘Natural Cycles’ for Marketing in the U.S.

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In August, FDA approved the marketing of a Swedish App called Natural Cycles – a tech-based method of contraception – in the country.

While the app has been in use across EU countries ever since it was certified by the concerned European organization for inspection and certification in February 2017, it was the first time an app-based form of contraception was being approved for use in the U.S

This method of contraception through fertility awareness, however, is not without its fair share of controversy.

In July, an investigation into the Natural Cycles marketing was initiated by the Advertising Standards Authority (ASA) in the U.K., after it received three complaints about the app and its paid ad on Facebook that vouches for the high accuracy of the app for use as contraception, based on clinical trials.

“We would require robust substantiation from any company to support such a claim,” an ASA spokesman said.

To be fair to Natural Cycles, its Facebook page is chock-a-block with user testimonials in support of the app as well, with one woman going to the extent of posting “the launch of a petition against any possibility of the app being banned in Sweden following the Medical Product Agency’s investigation,” the Guardian reported.

FDA spokesperson Deborah Kotz declined to comment on the ASA investigation, other than saying that the FDA expected Natural Cycles to follow the agency’s own set of marketing policies, according to VICE.

She did, however, acknowledge that the agency was aware of the investigation and had even contacted the Swedish authorities in that regard.

Electric Spine Implant Helps Three Patients Walk Again

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Three patients with waist down paralysis were able to walk again after doctors implanted an electrical device into their spines, reconnecting the severed communication between the neurons in their legs and brains.

The beneficiaries of this seemingly miraculous line of treatment included 29-year-old Jered Chinnock from Tomah, Wisconsin; Kelly Thomas, 23, from Homosassa, Florida; and Jeff Marquis, 35, belonging to Louisville, Kentucky.

Chinnock was the beneficiary of a spinal procedure performed by surgeons at the Mayo Clinic in Rochester, Minnesota, as part of a study that was published in the journal ‘Nature Medicine on Sep. 24.

https://www.nature.com/articles/s41591-018-0175-7

Thomas and Marquis underwent a similar procedure as voluntary participants in another study conducted at the Kentucky Spinal Cord Injury Research Center at the University of Louisville, also published on Sep. 24 in the ‘New England Journal of Medicine.’

https://www.nejm.org/doi/full/10.1056/NEJMoa1803588

Basically, the study involved implanting an array of electrodes below the injured section of the spine and a pacemaker-sized spinal cord stimulator under the skin in the abdominal region, with communication between the two established through a connecting wire.

The implanted devices were controlled remotely using a TV-type controller that allowed doctors to regulate the voltage and even target specific areas for stimulation.

However, the implants alone could not have achieved the level of recovery witnessed in the patients if they were not backed by intensive training in a controlled environment, overseen by trained professionals, and, of course, a ton of willpower on the patients’ part.

Uterus Transplant from Dead Donor Led to First Successful Childbirth

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Earlier this month, in an absolute first, a 32-year-old Brazilian woman gave birth to a healthy baby girl – thanks to a uterine implant from a dead donor.

The organ came from a 45-year-old unnamed woman who had voluntarily agreed to donate her organs before her death from brain hemorrhage; she had had three normal vaginal deliveries during her short lifespan.

The transplant took place in 2016, and the recipient gave birth to a perfectly normal baby girl weighing 2.5 kilograms (5.6 pounds) on Dec 15, 2017, through Caesarean section.

The achievement is all the more impressive if you consider that ten similar attempts in the U.S., Czech Republic, and Turkey had ended in failure, although successful birth using a uterus from a living donor has been achieved eleven times in the past.

Despite that, it isn’t a perfectly viable option because finding a woman who would willingly give away her uterus is never going to be easy unless a family member or a close friend agrees to make the sacrifice.

But the latest breakthrough opens the door for women with uterine infertility issues to have children of their own rather than going for adoption or surrogacy options.

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From The Editors Health

FDA Issues Stern Warning to Genetech for Marketing Unapproved Stem Cell Medicines

The U.S. Food and Drug Administration (FDA) on Thursday (Dec 20) said it had sent a letter to San Diego-based Genetech, Inc, warning the company for marketing non-FDA-approved stem cell products and for non-compliance with “current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements.”

The agency has also issued warning letters to other manufacturers and healthcare providers involved in non-FDA-approved stem cell treatments.

The rebuke came in the wake of recent cases of serious infections following unapproved stem cell therapies.

At least a dozen patients in three states fell critically ill after receiving non-FDA-approved stem cell injections derived from umbilical cord blood, said the U.S. Centers for Disease Control and Prevention (CDC) in a report published Thursday (Dec 20).

A CDC investigation team led by Kiran Perkins discovered that seven patients in Texas, four in Florida, and one in Arizona were seriously infected after receiving Genetech-processed and Liveyon-distributed stem cell injections or infusions.

The infections, ranging from bloodstream and joint infections to epidural abscesses, among others, were so serious that all twelve patients had to be hospitalized; thankfully, no deaths were reported.

FDA approval for stem cell use is subject to meeting two main criteria: one, all stem cell products have to be derivatives of umbilical cord blood, and two, they can only be used in hematopoietic and immunologic reconstitution.

The CDC findings reveal that as many as eleven of the twelve infected patients were treated for pain or orthopedic conditions, which are non-hematopoietic in nature and, therefore, constitute a breach of FDA guidelines.

“[The] investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses other than hematopoietic or immunologic reconstitution,” says the report.

It goes on to point out that “many companies, clinics, and clinicians continue to market products from various sources as treatment for orthopedic, neurologic, and rheumatologic conditions without FDA approval.”

“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients,” said FDA Commissioner Scott Gottlieb in a press release.

Gottlieb assured that not only was the FDA committed to introducing new policies to ensure safe manufacturing practices for stem cell-based medicines, it was also mobilizing additional resources for the proper enforcement of these policies.

“We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework,” said the FDA commissioner.

“These efforts include our work to encourage manufacturers to engage with the FDA early so that we can provide guidance about any applicable regulatory requirements,” Gottlieb added.

While the agency is steadfast about taking action against non-compliers, it also wants to ensure that patients are not deprived of access to “safe and effective regenerative medicine products as efficiently as possible,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Companies that fail to mend their ways are likely to face “enforcement action such as seizure, injunction or prosecution,” warns FDA.

Perkins and his team ran tests on sealed vials at the Texas and Florida clinics where the patients received treatment and arrived at the conclusion that the bacterial contamination of the products occurred before distribution, effectively putting the responsibility on questionable manufacturing practices.

“Umbilical cord blood cannot be decontaminated after collection because there are currently no validated processes for sterilization, so manufacture of derived products must be highly controlled to prevent distribution of contaminated products,” the researchers wrote in their report.

The fact that both Genetech and Liveyon are registered with FDA does not mean they have the agency’s approval for, respectively, processing and distributing these products.

“The Genetech-processed, Liveyon-distributed product is not FDA-approved or lawfully marketed,” says the CDC report.

“Though Genetech and Liveyon are registered with FDA, such registration is not a form of FDA approval,” it said, adding that “FDA registration alone does not demonstrate compliance of firms or their products with the law.”

The CDC appealed to healthcare givers and receivers to report “any adverse events related to treatment with the Genetech/Liveyon products or any unapproved stem cell therapies to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”

In the letter to Genetech, FDA’s Program Division Director for the Office of Biological Products Operations, Karlton Watson, listed several significant CGTP and CGMP deviations, in addition to the earlier deviations the agency had already informed the company about.

“FDA has found additional significant deviations upon further review of the information collected during the June 2018 inspection,” read the letter addressed to Genetech president Edwin N. Pinos.

“The deficiencies include, but are not limited to, the following,” Watson wrote, going on to list 19 instances of non-compliance, in detail.

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From The Editors Health

Chinese Start-Up Infervision is Changing the Way Diseases are Diagnosed

Based on Artificial Intelligence (AI) and its sub-disciplines like machine learning and deep learning, image recognition technology has become part of our everyday existence.

Whether its the facial recognition feature on your smartphone or Google’s image search capabilities, image recognition technology is all around us.

It is here not only to stay but also expand its applicability in more ambitious fields, such as medical diagnoses.

Not too long ago, doctors relied on their own trained eyes to read medical images like x-rays and CT scans and diagnosed diseases from what they saw.

Although they were accurate most of the times, human error was always a factor.

As a matter of fact, the old system of image analysis is still a part and parcel of healthcare in several developing countries.

Lung cancer is the leading cause of death in China where more than 600,000 people succumb to the dreaded disease every year, primarily due to high levels of air pollution.

With a shortage of radiologists in the country, the possibility of human error due to fatigue and overwork increases that much more, what with radiologists having to analyze hundreds of CT scan images every day.

Realizing that this was a problem that would only multiply with time, Infervision founder Chen Kuan decided to dedicate his deep learning and image recognition expertise to the field of medicine.

“In China there are just 80,000 radiologists who have to work through 1.4 billion radiology scans every year,” Kuan told Bernard Marr – a strategic business & technology advisor to governments and companies – last year.

“By using AI and deep learning, we can augment the work of those doctors. In no way will this technology ever replace doctors – it is intended to eliminate much of the highly repetitive work and empower them to work much faster,” he said.

Infervision tied up with the Szechwan People’s Hospital for a pilot project after which the company began working with several top hospitals in the country.

“So what I saw was that a lot of Chinese people, particularly those living outside big cities, do not get to have any regular medical check-up involving medical imaging,” Kuan told Bernard Marr – an internationally best-selling author, popular keynote speaker, futurist, and a strategic business & technology advisor to governments and companies – last year.

“So they often have to wait until they feel something wrong with their body before they go to a big hospital where it can be diagnosed,” by which time it was often too late to be able to do much about it, he said.

“So what we wanted to do is use deep learning to alleviate this huge problem. If we can use it to learn from the past and assist in diagnosing more accurately, we can help solve the problem,” he told Marr.

Infervision has already completed successful pilot tests of its Head CT Augmented Screening platform and has also been working on incorporating machine learning algorithms in the diagnosis and treatment of strokes.

The company used more than 100,000 annotated image scans to train the algorithms and as more live data keeps adding on, the system will become even more efficient at detecting two main stroke types – hemorrhagic and ischemic.

“X-ray is a very old type of medical check-up – in China, for example, no one had mentioned chest X-ray in academic conferences for more than 15 years,” Kuan told Marr. “Until very recently with the arrival of AI.”

“AI has helped radiologists discover problems they previously weren’t able to see. So we are very proud to see radiologists starting to discuss some very interesting and fantastic cases involving AI,” he said.

When Marr asked Kuan about the way radiologists and other related staff reacted to the new diagnostic technology, considering that it had the potential to replace them, the Infervision CEO said that they were, in fact, rather excited about the whole thing.

“They are very excited”, he told Marr. “Two or three weeks ago there was a congress of Chinese radiologists and there was a lot of excitement about what we can do,” he said.

“They realise that we are helping them with the diagnosis but also helping with treatment plans for patients too,” Kuan added.

At the RSNA (Radiological Society of North America) conference in Chicago this week (Nov 25 to Nov 30), Infervision announced it was expanding its machine learning and deep learning applications to include other chest conditions like cardiac calcification – a relatively common indication of early artery disease, which generally shows up on X-rays or CT scans.

“By adding more scenarios under which our AI works, we are able to offer more help to doctors,” Tech Crunch quoted Kuan as saying.

Doctors can easily identify several diseases from a single scan, something which AI needs to be taught (hence the term machine learning).

However, while a doctor takes 15 to 20 minutes to analyze an image, Infervision’s AI can do it in 30 seconds, complete with a report on the observations and with 20 percent more accuracy.

Currently, the Beijing start-up is associated with as many as 280 hospitals, and counting, with 20 of them outside of the country.

Based on Infervision’s track record, a number of western hospitals have changed their opinion about the company; they had been under the impression that Chinese companies lacked the expertise to deliver state-of-the-art solutions.

“Regardless of their technological capability, Chinese start-ups are blessed with access to mountains of data that no start-ups elsewhere in the world could match. That’s an immediate advantage,” Kuan told TechCrunch.

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From The Editors Health

First Successful Childbirth After Uterus Transplant From Dead Donor

Whether you look at it as a medical milestone or an act of Providence, the fact remains that a 32-year old Brazilian recipient of a uterus from a dead donor has given birth to a healthy baby-girl in an absolute first of its kind.

The organ came from a 45-year-old unnamed woman who had voluntarily agreed to donate her organs before her death from brain hemorrhage; she had had three normal vaginal deliveries during her short lifespan.

The beneficiary, whose identity is also not being made public, was suffering from a condition called  Mayer-Rokitansky-Küster-Hauser(MRKH) syndrome – a female reproductive-system-disorder that causes underdeveloped or totally missing uterus.

With no apparent abnormalities to the external genitalia of MRKH syndrome sufferers, the condition usually stays undiscovered until the affected woman is diagnosed with primary amenorrhea – failure to get menstrual periods by the age of sixteen.

The transplant took place in 2016, with the recipient giving birth to a perfectly normal baby girl weighing 2.5 kilograms (5.6 pounds) on Dec 15, 2017, through Caesarean section.

The achievement is all the more impressive if you consider that ten similar attempts in the U.S., Czech Republic and Turkey had ended in failure, although successful birth using a uterus from a living donor has been achieved eleven times since the first success in 2013.

Despite that, it’s not a perfectly viable option, in that finding a woman who would willingly give away her uterus is never going to be easy unless a family member or a close friend agrees to make the sacrifice.

However, the latest breakthrough opens the door for women with MRKH syndrome, or other uterine infertility issues, to have children of their own rather than going for adoption or surrogacy options.

Lead researcher of the procedure, Dr. Dani Ejzenberg, from Hospital das Clínicas at the University of São Paulo in Brazil, has published his “proof of concept” in the journal ‘Lancet.’

“The first uterus transplants from live donors were a medical milestone, creating the possibility of childbirth for many infertile women with access to suitable donors and the needed medical facilities,” said Dr. Ejzenberg.

“However, the need for a live donor is a major limitation as donors are rare, typically being willing and eligible family members or close friends,” he explained.

“The numbers of people willing and committed to donate organs upon their own deaths are far larger than those of live donors, offering a much wider potential donor population,” Dr. Ejzenberg added.

What also works in favor of using uteruses from deceased donors is the fact that it eliminates the risks attached to a live transplant, in addition to the relatively low costs it entails.

Out of the ten failed attempts using the dead donor method, one involved a 23-year-old woman who also had MRKF syndrome.

While the woman was successful in achieving pregnancy after getting a uterus from a dead donor in Turkey, he motherhood aspirations came to an abrupt halt when her pregnancy was terminated due to unforeseen complications merely six weeks after conception.

The recent success is a testimony to the determination of researchers who believed in the concept and continued to pursue the idea of effecting birth using the uterus of a dead donor.

Not only has the research opened a promising new avenue for childless couples throughout the world, but it also provides access to important information on how to see such pregnancies through to a full term for a successful delivery.

“Uterine transplant and subsequent pregnancies, including from live donors, have previously been reported, but this is the first case of a successful pregnancy from a deceased donor,” Andrew Shennan – professor of obstetrics at King’s College London, who was not part of the research – was quoted by the Independent as saying.

“Successful pregnancy, without evidence of any compromise in spite of the uterus (womb) being without oxygen for eight hours before transplant, was unique,” Shennan told the online newspaper.

The medical team after the baby's birth.
The medical team after the baby’s birth.

While there could have been a number of reasons behind Dr. Ejzenberg and his team’s success, timing was the key factor, believe the researchers.

The procedure involved removing sixteen eggs from the recipient’s functional ovaries five months prior to the transplant, out of which fifteen were fertilized and eight resulted in embryos which were preserved for implantation at a later date.

Seven months after the Sep 2016 transplant, with regular menstrual periods and no signs of organ rejection, one of the preserved embryos was implanted.

It was the timing of this implant that proved to be the key factor in achieving success.

In all of the failed attempts in the past, the embryo implant was done at least a year after the uterus transplant.

While it is not confirmed that the early implant actually made the difference between success and failure, researchers believe it’s a highly plausible rationale.

As is typically the case in transplants like this, the uterus was removed during delivery to eliminate complications from having to take immunosuppressants to fight rejection.

“The only other pregnancy following a uterine transplantation from a deceased donor was in 2011 in Turkey,” said Dr. Srdjan Saso, from the Imperial College London – also quoted by the Independent.

“This attempt was unsuccessful and led to miscarriage two years later, which led to doubts whether deceased donation could work,” he reportedly said.

“Our hope, as we plan to kick-start the UK programme at the beginning of 2019, is for the deceased donor uterine transplant programme to grow alongside its ‘live donor’ counterpart, prove achievable and successful so that both women with willing donors in their families, and those not, can have a real option of carrying a healthy pregnancy,” Dr Saso concluded.

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From The Editors Health

China Orders Researcher He Jiankui to Stop Work on Genetically-Engineered Babies

Chinese researcher He Jiankui from the Southern University of Science and Technology in Shenzhen, China, shocked the scientific community and the world at large on Monday (Nov 26) when he announced that he had successfully created the planet’s first genetically-altered human babies.

Jiankui’s claims were neither backed by any independent substantiation nor had the findings been published in any scientific journal where it could be scrutinized by experts in the field.

His work, which academics say is “unconscionable” and of “grave ethical concern”, also flouts the stringent rules governing the use of gene-editing techniques on humans.

His university has claimed ignorance about the experiment, saying the researcher had been on unpaid leave since February, and that the university would soon initiate an investigation into the matter.

Speaking to state-run media outlet China Central Television (CCTV), China’s vice minister of science and technology, Xu Nanping, condemned Jiankui’s research, saying it was unethical and in stark violation of the country’s laws governing the subject.

“The genetically edited infant incident reported by media blatantly violated China’s relevant laws and regulations,” CCTV quoted the minister as saying on Thursday.

“It has also violated the ethical bottom line that the academic community adheres to,” Xu told the news outlet, adding that it was “shocking and unacceptable” and that the Chinese government was “resolutely opposed to it.”

Although he said his ministry had ordered an investigation, he did not highlight specific actions taken by the government.

Jiankui’s Monday announcement sent shockwaves across the scientific community, prompting several scientists to condemn the researcher’s genetic experimentation with human embryos.

Dr. Sarah Chan, a bioethicist at the University of Edinburgh, said the experiment was “of grave ethical concern,” if there was any truth in the claim.

“Whether or not the veracity of these reports is eventually borne out, making such claims in a way that seems deliberately designed to provoke maximum controversy and shock value is irresponsible and unethical,” The Guardian quoted Dr. Chan as saying.

“The claim made by those responsible for the research is that the babies have been genome-edited in an attempt to make them immune to HIV,” she added.

“The lifetime risk of contracting HIV is extremely low in the first place; there are other means of prevention and it is no longer an incurable, inevitably terminal disease,” said Dr. Chan, adding that “putting these children at such drastic risk for such a marginal gain is unjustifiable.”

“If true, this experiment is monstrous. The embryos were healthy – no known diseases,” Prof. Julian Savulescu, an expert in ethics at the University of Oxford, was quoted by BBC as saying.

“Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer,” Savulescu said.

“There are many effective ways to prevent HIV in healthy individuals – for example, protected sex. And there are effective treatments if one does contract it,” the Oxford professor added.”

Defending his work at the International Summit on Human Genome Editing in Hong Kong on Wednesday (Nov 28), Jiankui said he was proud of his achievement, calling it a “wonderful progress in HIV therapy.”

Although he said he had submitted his study findings for review by a scientific journal, he didn’t reveal the name of the concerned journal.

The beleaguered researcher was scheduled to address the conference again on Thursday, but he left Hong Kong, saying through a spokesman-delivered statement: “I will remain in China, my home country, and cooperate fully with all inquiries about my work. My raw data will be made available for third party review.”

“How can a scientific experiment with so many uncertainties be kept as a secret for such a long time?” questioned He Kaiwen, a researcher at Interdisciplinary Research Centre on Biology

“This shows that there’s huge problem with the transparency of scientific research,” she said.

“This is a completely new situation. This question is one we have never faced before,” Keiwen added.

Center for Genetics and Society Wednesday issued a civil society statement to the organizers of the Hong Kong summit.

The statement which so far has 142 signatories, including 129 individuals and 13 organizations, says:

“The undersigned individuals and organizations wish to express our dismay and outrage at He Jiankui’s claims of creating genetically engineered babies.

“Though these claims are unverified, his actions violate a key provision of the concluding statement issued at the First International Summit on Human Gene Editing in 2015, that such dangerous experiments should not proceed until there was broad societal consensus in their favor.”

The statement goes on to condemn what it calls the “rogue actions” of Jiankui for taking such a “consequential decision” all by himself, calling on governments and the United Nations to legislate enforceable regulations to ban “reproductive experiments with human genetic engineering.”

It says that such moratoria are necessary to discourage an international one-upmanship in genetic-engineering, that would potentially lead to “a new form of eugenics.”

“If the summit and other scientific bodies do not act, it will fall to civil society and policy makers to do so, in order to ensure the avoidance of disastrous consequences for global society,” the statement warns.

The organizing committee – including the U.S. National Academy of Sciences and U.S.

National Academy of Medicine, the Royal Society of the United Kingdom, and the Chinese Academy of Science – released a statement of its own at the conclusion of the summit.

It said that changes to the DNA of embryos or gametes had its potential benefits, but warned that “heritable genome editing of either embryos or gametes poses risks that remain difficult to evaluate.”

“Germline editing could produce unintended harmful effects for not just an individual but also for that individual’s descendants,” said the committee’s statement.

“Changes to a particular trait may have unanticipated effects on other traits that could vary from person to person and in response to environmental influences,” it added.

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From The Editors Health

New Study Suggests Mitochondrial DNA Can Also Be Passed Down From Dad

Contrary to conventional belief that mitochondrial DNA (mtDNA) is generally passed down from mother to offspring, particularly in humans, a new study claims to have identified three “unrelated multigeneration families” in which 17 individuals were found to have inherited a good part of their mtDNA, ranging from 24% to 76%, from their father.

Unlike the rest of our DNA, which reside within the cell nucleus, mtDNA exists separately inside the mitochondria within each cell.

The study, which was led by Dr. Taosheng Huang from the Division of Human Genetics at the Cincinnati Children’s Hospital Medical Center in Ohio, was published Monday (Nov 26) in the  Proceedings of the National Academy of Sciences (PNAS).

So entrenched is the belief that mitochondria are inherited from the mother’s side that it is often referred to as the Eve Gene – the logic behind the misnomer being that it can, potentially, be traced back to some primordial matriarch of all humans.

The findings do not only put a big question mark on genetic testing to determine maternal ancestry, but it could also change the way mitochondrial diseases are treated today.

Dr. Huang and his team found their first case of biparental inheritance of mtDNA in a four-year-old boy suffering from fatigue, muscle pain, and other symptoms that hinted at a possible mitochondrial disorder.

Not satisfied with the results of the first sequencing of the boy’s mitochondria, which he thought was “impossible,” Dr. Huang ran subsequent tests at different research labs just to be sure no mistakes were made the first time.

However, each time the results told the same story; Dr. Huang’s four-year-old patient was carrying biparental mitochondrial DNA.

This meant the boy had two sets of mtDNA – one from his mother, which was normal, and the other from his father, which was an aberration – at least as far as the established belief in this regard is concerned.

In pursuance of further confirmation, Dr. Huang and his team tested the boy’s sisters and found the same evidence of biparental mtDNA transmission, which led them to test their mother and, again, the result was no different.

Still not 100 percent convinced, or perhaps in pursuance of more conclusive evidence, the team ran tests on the mother’s parents too, and guess what, 60 percent of her mtDNA came from her mother, while 40 percent had been passed down from her father.

Determined to pursue this further, the researchers ended up identifying 17 individuals from three unrelated families who were carrying biparental mtDNA.

Ten of these mixed mtDNA carriers belonged to the boy’s family alone, while the remaining seven were from the other two unrelated families.

“This upends entire fields based on genetics: under exceptional circumstances, mitochondrial DNA can be passed from father to offspring,” tweeted Trevor Branch – an associate professor at the University of Washington who was not involved in the study.

“This is a really groundbreaking discovery,” Xinnan Wang, a biologist at the Stanford University in California – also not part of the study – was quoted by NOVA Next as saying.

“It could open up an entirely new field… and change how we look for the cause of [certain] diseases,” he told NOVA.

While the original belief that mtDNA is generally a maternal inheritance still stands, the findings do indicate that there are exceptions.

Potentially, the discovery can play a significant role in developing more effective ways for treating mitochondrial diseases, say the researchers.

“Our results suggest that, although the central dogma of maternal inheritance of mtDNA remains valid, there are some exceptional cases where paternal mtDNA could be passed to the offspring,” the researchers wrote in their paper.

“Elucidating the molecular mechanism for this unusual mode of inheritance will provide new insights into how mtDNA is passed on from parent to offspring and may even lead to the development of new avenues for the therapeutic treatment for pathogenic mtDNA transmission,” the authors wrote.

While it’s a fact that each one of us carries a mix of both our parents’ genes, it only holds true in the nucleus.

However, DNA is not just restricted to a cell’s nucleus but also found in the cell’s mitochondria, the so-called “power centers” of the cell, and are referred to as mitochondrial DNA, or mtDNA.

In nearly all known animals, the mtDNA is an exclusive maternal inheritance; hence the “Eve Gene” moniker and the established practice of sequencing mtDNA to determine maternal ancestry.

In our embryonic form, we receive mitochondrial DNA from both Mom and Dad, but Dad’s mtDNA gets discarded long before birth; the reason why this happens still remains a genetic mystery that needs to be researched further.

It is not uncommon for mutant mitochondrial genes to co-exist with healthy ones inside cells, often causing serious diseases; however, the intensity of the affliction is determined by the proportion of mitochondria carrying the mutant gene.

For example, a woman carrying low levels of defective mitochondria can easily pass on higher concentrations to her offspring, with far more serious consequences than what she may have herself experienced.

Apart from the three families researched for the paper, Dr. Huang and his team have traced several other families with biparental mtDNA that are potential subjects for more research.

According to the team, an estimated 1 in every 5,000 individuals has mtDNA from both parents, which is indicative of the fact that biparental transmission of mtDNA may not be as few and far between as was previously thought.

“Clearly, these results will need to be brought in agreement with the fact that maternal inheritance remains absolutely dominant on an evolutionary timescale and that occasional paternal transmission events seem to have left no detectable mark on the human genetic record,” wrote the team.

“Still, this remains an unprecedented opportunity in the field.”