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From The Editors Health

Chinese Scientist Lays Claim to Creating World’s First Gene-Edited Human Babies

A researcher at the Southern University of Science and Technology in Shenzhen, China, has claimed to have successfully created the planet’s first genetically-modified babies.

He Jiankui, who also goes by the moniker JK, told the Associated Press that he was able to genetically alter seven different embryos during fertility treatments, with only one pregnancy to show for his efforts, so far.

Jiankui also revealed the breakthrough on Monday in Hong Kong to one of the organizers of an international conference on gene editing, due to commence on Tuesday.

“I feel a strong responsibility that it’s not just to make a first, but also make it an example,” JK said.

“Society will decide what to do next,” he added, probably alluding to the ethicality and acceptability of the controversial procedure.

JK told AP that his aim was not to prevent or find a cure for an inherited disease but rather to create the ability to resist possible future HIV and AIDS infection, a trait few people are naturally blessed with.

“Two beautiful little Chinese girls, named Lulu and Nana, came crying into the world as healthy as any other babies a few weeks ago. The girls are home now with their mom Grace and dad Mark,” he said in a He Lab-recorded statement.

The He Lab has made it clear that in the interest of the concerned family’s privacy, both Lulu and Nana are pseudonyms; it’s likely that the names JK gave for the parents are pseudonyms too.

He said that Grace started her pregnancy by regular IVF (In vitro fertilization) but with a difference, in that immediately after depositing Mark’s sperm into her eggs, he also sent proteins and instructions for a genetic surgery intended to purge the genes that would make them vulnerable to HIV.

“When Lulu and Nana were just a single cell, this surgery removed the doorway through which HIV enters to infect people,” JK said.

Before returning the twins to Grace’s womb a few weeks later, JK and his team did a full genome sequencing to check how the surgery had gone and found that the results were as satisfactory as expected.

The twins’ genomes were deep sequenced again after birth and again everything was found to be exactly as intended.

“No gene was changed except the one to prevent HIV infection,” said a proud JK.

He went on to say that the birth of the twins has given Mark – an HIV patient – “a reason to live, a reason to work, a purpose.”

Discrimination in many developing countries makes matters worse for HIV positive and AIDS sufferers, JK explained.

“Employers fire people like Mark, doctors deny medical care, and even forcibly sterilize women,” he said.

He reasons that protecting a child from “a lethal genetic disease like cystic fibrosis or from a life threatening infection like HIV” through gene surgery not only gives the child an “equal chance at a healthy life” but also heals the whole family.

To make the surgery possible, JK used a powerful gene-altering tool called CRISPR-cas9 – a technology that can effectively remove an undesired disease-causing gene, or add one that is needed, by removing or replacing sections of the DNA as the case may be.

What’s important to note is the fact that there is no independent substantiation of JK’s claim, at least not yet, and neither has the findings been published in any scientific journal where it can be scrutinized by experts in the field.

The announcement has come as a shock to many in the scientific community; in fact, several scientists have been pretty vocal in their condemnation of JK’s genetic experiment on humans.

One of them is Dr. Sarah Chan, a bioethicist at the University of Edinburgh, who says that the experiment is of “of grave ethical concern,” if there was any truth in the claims.

“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.”

Calling the experiment “unconscionable,” Dr. Kiran Musunuru – a gene-editing expert at the University of Pennsylvania – said that the human experiment was “not morally or ethically defensible.”

“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.

He also said that “this experiment exposes healthy normal children to risks of gene editing for no real necessary benefit.”

Dr. Eric Topol, head of the Scripps Research Translational Institute in California, said that the experiment was “far too premature,” according to The Associated Press.

“We’re dealing with the operating instructions of a human being. It’s a big deal,” Dr. Topol said.

Meanwhile, known geneticist and molecular engineer, George Church, from Harvard University  in Cambridge, Massachusetts, has justified Jiankui’s initiative toward preventing HIV – “a major and growing public health threat.”

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From The Editors Health

Neuroscientist Prof. George Paxinos Discovers Hidden Region in the Human Brain

Prof. George Paxinos – a neuroscientist of international repute – and his team at NeuRA (Neuroscience Research Australia) have discovered an “intriguing” region of the human brain that had remained undetected for as long as it did.

Prof. Paxinos has Christened his discovery Endorestiform Nucleus, and not without reason, as it pertains to a location close to where the brain meets the spinal cord.

Although Prof. Paxinos had long suspected the existence of the Endorestiform Nucleus, he didn’t have the straining and imaging techniques to actually validate his theory, until now.

“The region is intriguing because it seems to be absent in the rhesus monkey and other animals that we have studied,” the NeuRA website has quoted the professor as saying.

“This region could be what makes humans unique besides our larger brain size,” the professor said.

What the professor is, basically, implying is that the dexterity and precise motor movements that humans are blessed with is probably due the existence of this region in the brain, which, as mentioned, has not been detected in animals that he has researched.

“I cannot imagine a chimpanzee playing the guitar as dexterously as us, even if they liked to make music,” Paxinos told ScienceAlert.

The Endorestiform Nucleus is located within the inferior cerebellar peduncle, an area in the brain that assimilates sensory input and motor vestibular functions to finetune our posture, balance and motor movements.

“I can only guess as to its function, but given the part of the brain where it has been found, it might be involved in fine motor control,” said Prof. Paxinos, according to the NeuRA site.

In his long and distinguished career, Prof. Paxinos has produced several atlases of the brain.

An MRI/DTI Atlas of the Rat Brain, The Rat Brain in Stereotaxic Coordinates, Atlas of the Spinal Cord, The Spinal Cord, and The Mouse Nervous System are but a few examples from his vast repository of books and atlases.

He launched his book The Brain Atlas as recently as March 2018 in Canberra, while he was on a three-day visit to the Australian capital to take part in the “Brains on the Hill” event.

Australian Brain Alliance (ABA) researchers from across the continent-country had assembled there to interact with politicians and parliamentarians and showcase Australia’s latest and most advanced neurotechnologies.

“We met with over 75 Senators and MPs, and we showed our representatives that the Australian Brain Initiative is integral in preparing Australia for the next century,” ABA Chairperson Professor Linda Richards said about the event.

So accurate and popular are Prof. Paxinos’ brain atlases that neuroscientists across the world use them in their research work.

“Professor Paxinos’ atlases showing detailed morphology and connections of the human brain and spinal cord, provide a critical framework for researchers to test hypotheses from synaptic function to treatments for diseases of the brain,” the NeuRA website quotes Prof. Peter Schofield, CEO at NeuRA, as saying.

Natalie Farra, Senior Editor at Elsevier – an international multimedia publishing house behind most, if not all, of Prof. Paxinos’ books – said:

“It is truly an honour for Elsevier to be continuing Professor Paxinos’ legacy of publishing with us.

“His books are world-renowned for their expertise and utility for brain mapping, and for their contributions to our understanding of the structure, function and development of the brain.”

The discovery of the Endorestiform Nucleus could, potentially, play a significant part in helping researchers find a cure for debilitating brain disorders such as Parkinson’s Disease and motor neuron diseases (MND).

Speaking to ScienceAlert, Prof. Paxinos said that “the inferior cerebellar peduncle is like a river carrying information from the spinal cord and brainstem to the cerebellum,” adding that “the endorestiform nucleus is a group of neurons, and it is like an island in this river.”

He also told ScienceAlert:

“The endorestiform nucleus is all too evident by its dense staining for [the enzyme] acetylcholinesterase, all the more evident because the surrounding areas are negative,”

“It was nearly the case the nucleus discovered me, than the other way around.”

Meanwhile, neuroscientist Lyndsey Collins-Praino from Adelaide University, who was not part of the research, told ScienceAlert that it was too early to determine the true significance of the “intriguing” discovery.

“While one can speculate that the endorestiform nucleus may play a key role in [the functions of the inferior cerebellar peduncle], it is too early to know its true significance,” she said.

It’s also a bit early in the day to say with conviction that the endorestiform nucleus is unique to humans; a lot more work is required before definite conclusions can be arrived at.

Prof. Paxinos has detailed his findings in his latest book entitled ‘Human Brainstem: Cytoarchitecture, Chemoarchitecture, Myeloarchitecture.’

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From The Editors Health

U.K. Companies Considering Microchip Implants for Employees to Boost Security

In what is being seen by many as a ridiculous bid to augment security and stop access to sensitive areas, U.K. companies are reportedly exploring their options to literally get under their employees’ skin by microchipping them.

Biohax International, a Swedish tech company specializing in human chip implants, told the Sunday Telegraph that it was in talks with several legal and financial firms in the U.K., including a “major” player with hundreds of thousands of staff on its payroll, about fitting their employees with the £150 device, not bigger than a grain of rice.

”These companies have sensitive documents they are dealing with,” said Biohax founder and former professional body piercer Jowan Österlund.
“[The chips] would allow them to set restrictions for whoever,” he told the publication.

As insensitive as it may sound, Österlund’s justification is understandable as Biohax stands to gain hugely should the talks materialize into something concrete – read lucrative microchipping contracts for the company.

Microchipping someone would entail implanting the tiny device in the fleshy part between the thumb and the index finger (forefinger).

X-Ray showing microchip implant between the thumb and index finger (Image: Biohax)
X-Ray showing microchip implant between the thumb and index finger (Image: Biohax)

X-Ray showing microchip implant between the thumb and index finger (Image: Biohax)

The prospect of being microchipped by employers is being looked at by workers and certain organizations as a breach of employees’ right to privacy.

A spokesperson for the Confederation of British Industry (CBI), which represents 190,000 businesses comprising some 1,500 direct and 188,500 indirect members, was quoted by the Guardian to have said that it made for “for distinctly uncomfortable reading.”

Here’s what he told the British daily newspaper.

“While technology is changing the way we work, this makes for distinctly uncomfortable reading.

“Firms should be concentrating on rather more immediate priorities and focusing on engaging their employees.”

Trades Union Congress general secretary Frances O’Grady is concerned that companies may use coercive tactics to microchip their workers.

“We know workers are already concerned that some employers are using tech to control and micromanage, whittling away their staff’s right to privacy,” O’Grady told the Guardian.

“Microchipping would give bosses even more power and control over their workers,” he added, going on to say that “there are obvious risks involved, and employers must not brush them aside, or pressure staff into being chipped.”

Österlund is of the opinion that bigger companies with 200,000 or more workers should make microchipping optional for them, saying that even “if you have a 15% uptake that is still a huge number of people that won’t require a physical ID pass.”

BioTeq is another microchipping company offering the implants to, both, businesses and individuals, with 150 successful implants in the U.K. to its credit.

In fact, the founder and owner of the Hampshire -based company, Steven Northam, has the distinction of being the first Britisher to be microchipped.

This is what he told BusinessCloud in an interview in September this year.
“I thought it was quirky and that there were interesting things you could do with the tech.

“I had the chip fitted almost a year ago and recently bought a house, so I thought instead of fitting a lock I’ll fit a swipe-card entry so I can get in with my hand, start my car, all sorts of stuff.

“I didn’t really have any concerns about having it done, it was quite straightforward.”

Northam told the Guardian that BioTeq had also microchipped employees of a bank interested in testing the technology and that it had even shipped the tiny implants to Spain, France, Germany, Japan and China.

He also said that all directors at BioTech and IncuHive, one of the other companies he owns, have been microchipped.

Three out of the Big Four auditors, including KPMG, PricewaterhouseCoopers, and Ernst & Young, have said that they are not considering microchipping their employees, with the fourth biggie, Deloitte, declining to comment, the Guardian reported.

If the Biohax website is anything to go by, the company will soon have a presence in London.

The company also claims to have microchipped 4,000 people – a majority of them in Sweden – and says that is working closely with Statens Järnvägar, the state-owned Swedish rail company, to enable passengers to travel using chip plants instead of tickets.

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From The Editors Health

FDA Approves Powerful New Opioid ‘Dsuvia’ Despite Fears of Possible Abuse

In a move that went against the recommendations of Dr. Raeford Brown, chairman of the FDA advisory committee for evaluation of analgesic products, the U.S. Food and Drug Administration on Friday approved Dsuvia as a fast-acting substitute for intravenous painkillers used in hospitals across the nation.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) had voted 10 to 3 favoring the approval last month in a meeting that Dr. Brown was unable to attend due to prior commitments.

However, in a letter addressed to top FDA officials, including FDA commissioner Dr. Scott Gottlieb, Dr. Brown expressed serious doubts about the agency’s ability to regulate the potentially dangerous opioid in a manner that ensured its use “only in closely controlled settings” and appealed to them to reject it.

Writing on behalf of the non-profit consumer advocacy organization Public Citizen, De Brown suggested that the only way forward was the education of all prescribers about the potential dangers of abuse of the sublingual medication – something he said the FDA had failed to establish with other opioids.

“Given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label,” he said in the letter, signed by three other Public Citizen members.

Manufactured by California-based AcelRx Pharmaceuticals Inc., Dsuvia is the brand name for the drug sufentanil – an opioid believed to be 1,000 times more effective than morphine and 10 times more potent than fentanyl.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group and one of the signatories of the letter.

“It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die,” he said without mincing his words.

“It is likely, if not certain, that Dsuvia will be banned after ‘enough’ such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms,” Dr. Wolfe added.

Sufentanil has been in use since as far back as the early eighties, but only as an intravenous agent by clinicians in hospital settings, and is known to have killed abusers with their very first dose.

The opioid is extremely potent and poses “substantial risks of respiratory depression, diversion, abuse, and death,” explains Dr. Brown.

“I have witnessed this in resuscitating physicians, medical students, technicians, and other healthcare providers, some successfully, as a part of my duties as a clinician in a major academic medical center,” he said.

Justifying the FDA’s decision to approve Dsuvia, Dr. Gottlieb said that the agency’s decision was an effort to fight the opioid epidemic that the nation has been confronted with for some time now.

He said that the medicine would be administered by healthcare professionals in certified medically-supervised health care settings, including hospitals, surgical centers, and emergency departments.

He assured that stringent restrictions were being imposed on the distribution and use of Dsuvia, saying that the agency had “learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis.”

“We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug,” he said.

Opioid prescribing, opioid dependence and opioid overdose deaths have been on the rise in the U.S. and have increased four times in the last three decades.

Medicare-insured senior citizens are the most affected by this opioid over-indulgence and it wouldn’t be an overstatement to say that the crisis has taken epidemic proportions.

The elderly are more susceptible to the risks involved not only in the protracted use of opioids and opioid overdose but also when low-intensity opioids are administered over shorter periods of time.

This is because of their vulnerability to the sleep-inducing side effects of the drug, with most Medicare seniors having a history of falls, fractures and broken bones.

In a move to counter the deepening opioid crisis in the country, President Trump had said last year that he was seriously considering the option of declaring a national emergency in that regard.

“It’s a national emergency. We’re going to spend a lot of time, a lot of effort, and a lot of money on the opioid crisis,” Trump had told reporters at his Bedminster golf club in New Jersey.

“It is a serious problem, the likes of which we’ve never had. You know, when I was growing up, they had the LSD, and they had certain generations of drugs. There’s never been anything like what’s happened to this country over the last four or five years,” he said.

Meanwhile, AcelRx CEO Vince Angotti has said that the company would strictly adhere to an FDA-approved safety program, referred to as Risk Evaluation and Mitigation Strategies program, which involves proper regulatory measures such as distribution monitoring, auditing wholesalers, and ensuring that hospitals and health care providers follow the set norms.

“The approval of DSUVIA, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” Angotti said.

“We believe the unique features of DSUVIA are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of DSUVIA through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program.”

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From The Editors Health

Electrical Spine Implant Helps Three Paralyzed Patients Walk Again

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 their brains.

The recipients 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 Monday (Sep. 24) in the journal ‘Nature Medicine.’

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 are controlled remotely using a TV-type controller that allows doctors to regulate the voltage and even target specific areas for stimulation.

But, 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.

While the procedure can likely bring about varying levels of mobility in SCI patients with some residual sensation below the injury level, the same can’t be said about patients with no sensation at all.

“The current study showed that recovery of walking, standing, and trunk mobility can occur under special circumstances with intensive training and electrical stimulation years after a spinal cord injury that caused complete leg paralysis,” study author Claudia A. Angeli (Ph.D.) and her co-authors wrote in the New England Journal of Medicine-published article.

“Persons with some degree of spared sensation below the level of injury may be more suitable candidates than those with no sensation, but this, and the durability of over-ground walking, requires investigation in larger groups of patients with spinal cord injury,” the authors concluded.

Three individuals – a father, a student and a chef – had their lives rudely interrupted and brought to a sudden standstill, literally, when they were left paralyzed after sustaining serious injuries to their spines in different mishaps, involving a snowmobile, a truck, and a mountain bike, respectively.

Fate had dealt them a cruel hand, leaving them with broken bodies; but could not break their spirit; their will to be able to walk again.

Here’s a brief look into each of their stories.

Jered Chinnock, 29, (Tomah, WI)

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On that fateful day in February 2013, Jered Chinnock was having the time of his life with family and friends on a frozen lake in his neighborhood when his world came crashing down around him.

The snowmobile he was riding on hit a bump and he was thrown off it, right into the path of another snowmobile coming from behind.

“I just thought I got the wind knocked out of me and needed to catch my breath and released I couldn’t get up,” the Daily Mail has quoted him as saying.

The father-of-one sustained life-threatening injuries, including broken ribs, a punctured lung, and as many as three fractures to his spine.

While surgeons at the Mayo Clinic in Rochester, Minnesota, were able to save his life, he wasn’t able to regain voluntary control of movement in his legs; in fact, he was incapable of any movement below the mid-torso level.

The surgeons repaired the damage to the spine using screws, but they had no solution, whatsoever, to fix the severed nerves responsible for ferrying signals back and forth from the brain to the legs.

“I was just pretty much set in my ways of going to be in my wheelchair the rest of my life,” Chinnock said – again, as quoted by the Daily Mail.

Having spent more than three years on a wheelchair, Chinnock got his ray of hope in 2016, when researchers at the Mayo Clinic put him on a program that combined rigorous physical therapy for a period of 22 weeks, followed by the electrode and spinal cord stimulator implants mentioned earlier.

Barely two weeks had passed after the implants when Chinnock was able to stand unaided and even managed to move his legs while suspended in a harness as if walking on air.

All Chinnock needs to do is think about standing or walking and the implanted system will come into play, allowing the exchange of signals between brain and legs.

“[Chinnock] was able to regain voluntary control of the movement in his legs. The patient’s own thoughts were able to drive this,” said Dr. Kendall Lee, a neurosurgeon at the Mayo Clinic whose team performed the surgery.
“We were able to get him to stand independently and be able to take his own steps.”

Kelly Thomas, 24, (Homosassa, FL)

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On another fateful day, this time in July 2014, another life was drastically curtailed when Kelly Thomas’ truck flipped over multiple times before hitting a tree in a crash that left her paralyzed.

She regained consciousness in a hospital a couple of weeks after the crash, only to find out she had lost control of all movement from the chest down; Thomas was only 19 at the time.

Thomas underwent a similar procedure – weeks of physical therapy followed by implants, and all – and she’s now able to walk, although she has to focus hard on each step – and she can even talk as walks.

“The first day I took steps on my own was an emotional milestone in my recovery that I’ll never forget as one minute I was walking with the trainer’s assistance and, while they stopped, I continued walking on my own,’ she said in a press release.

She has gained back most of her muscle mass, gone is the nerve pain in her right foot, she has improved control over her bladder, and what’s more is that the implant has restored sexual function.

“I love it,” she says – about the implanted stimulator, in case you were wondering.

Jeff Marquis, 35, (Louisville, KY)

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Jeff Marquis, a chef and an avid mountain biker, was living in Whitefish (Montana) when fate reared its ugly head once again.

“I was going down a trail that had a bunch of jumps that I normally skipped,” Marquis, who has, since, relocated to Louisville, Kentucky, told NBC News.

“That day, I hadn’t really decided whether I was going around them or I was going to try it for once. I went over it without jumping and I ended up breaking my neck.”

Marquis’ comeback story is more or less the same as Chinnock’s and Thomas’, although his rehabilitation took a little longer before he was able to take his first baby steps unaided.

“The first steps after my mountain biking accident were such a surprise, and I am thrilled to have progressed by continuing to take more steps each day,” he said in a press release.

Marquis says his stamina has improved and that he has “regained strength and the independence to do things I used to take for granted like cooking and cleaning.”

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From The Editors Health

STD Cases in the United States Have Risen Alarmingly for the Fourth Year Straight, Says CDC

The United States has witnessed an alarming spike in sexually transmitted diseases (STD), including chlamydia, gonorrhea and syphilis, for the fourth year running, the Centers for Disease Control and Prevention (CDC)

revealed Tuesday (August 28) at the National STD Prevention Conference in Washington.

According to the CDC’s preliminary figures, in 2017 alone, a record 2.29 million new cases of chlamydia, gonorrhea and syphilis were diagnosed in the United States, breaking the previous year’s record by a whopping 200,000-plus cases.

Based on its preliminary data for 2017, here’s a CDC analysis of the number of STD cases diagnosed in 2017 as opposed to the STD cases reported in 2013, to give you an idea of the kind of jump witnessed in the last four years, which is really frightening, to say the least.

“Gonorrhea diagnoses increased 67 percent overall (from 333,004 to 555,608 cases according to preliminary 2017 data) and nearly doubled among men (from 169,130 to 322,169). Increases in diagnoses among women — and the speed with which they are increasing — are also concerning, with cases going up for the third year in a row (from 197,499 to 232,587)” – (CDC)

Caused by the Neisseria gonorrhoeae (gonococcus) bacterium, gonorrhea is an STD with painful symptoms that can range from penis discharge and severe burning during urination to testicular pain, in the case of men, while female symptoms include vaginal discharge, vaginal bleeding, pelvic pain, or burning with urination.

Gonorrhea can spread through any form of sexual contact and although curable with antibiotics, it can cause serious and sometimes fatal complications if left untreated.

One of the major causes for concern, as far as gonorrhea is concerned, is the disease’s progressive resistance to antibiotics, which has now become so critical that nearly every class of antibiotic has become redundant against the disease, with ceftriaxone remaining the single effective option for treating gonorrhea in the United States.

However, Gail Bolan – M.D., director of CDC’s Division of STD Prevention – says that, sooner or later, gonorrhea will develop ceftriaxone-resistance, too.

“We expect gonorrhea will eventually wear down our last highly effective antibiotic, and additional treatment options are urgently needed,” she said.

“We can’t let our defenses down — we must continue reinforcing efforts to rapidly detect and prevent resistance as long as possible,” Bolan added.

“Since 2015, CDC has recommended health care providers prescribe a combination of two drugs to people diagnosed with gonorrhea, a single shot of ceftriaxone and an oral dose of azithromycin,” Bolan also said.

“That approach seems to be working,” she said, adding that “emerging resistance to ceftriazone has not been seen since the dual therapy approach was implemented, and there has not yet been a confirmed treatment failure in the United States when using the recommended therapy.”

Experts at the Tuesday conference appeared unanimous in their summation that gonorrhea’s resistance to practically all class of antibiotics was indeed cause for concern and appropriate measures on a war footing was the need of the hour.

Infectious disease expert with the University of Alabama at Birmingham, Dr. Edward Hook said that despite the severity of the antibiotic-resistance issue, “the number of new antibiotics available and the development of new antibiotics has slowed greatly,” in the last couple of decades.

“So we have this continued inexorable process of the gonococcus developing antimicrobial resistance, coupled with fewer new antibiotics to pick up and take care of the problem if it develops,” he said. “That’s a very troublesome combination.”

Dr. Bruce Farber – Chief of Infectious Diseases at North Shore University Hospital in Manhasset, N.Y., and at Long Island Jewish Medical Center in New Hyde Park, N.Y. was quoted by HealthDay, earlier this year, as saying that “resistant gonorrhea already is all over the United States.”

He added: “It’s maybe not a strain like that you’ve just read about from the U.K., which is extraordinary, but nevertheless generally these cases are occurring.”

He was referring to a gonorrhea case diagnosed in England earlier in the year, in which the affected man could not be cured because of his resistance to all of the commonly used antibiotics.

“Primary and secondary syphilis diagnoses increased 76 percent (from 17,375 to 30,644 cases). Gay, bisexual and other men who have sex with men (MSM) made up almost 70 percent of primary and secondary syphilis cases where the gender of the sex partner is known in 2017. Primary and secondary syphilis are the most infectious stages of the disease.” – (CDC)

Brought on by the bacterium Treponema pallidum, syphilis is largely the result of sexual promiscuity and prostitution.

However, a pregnant woman with syphilis can also transmit the disease to her baby during gestation or at birth, causing congenital syphilis.

Not only are there different types of syphilis but there are different stages as well, all of which can be treated accordingly but, again, if treatment is not received early enough it can have long-term and painful consequences, including increased HIV risk.

“Chlamydia remained the most common condition reported to CDC. More than 1.7 million cases were diagnosed in 2017, with 45 percent among 15- to 24-year-old females.” – (CDC)

Chlamydia, the most common among the three STDs in question, as the CDC data shows, is caused by the Chlamydia trachomatis bacterium and has gonorrhea-like symptoms for both men and women.

Generally spread through any form of sexual contact, it can also be transmitted from mother to baby during labor.

Avoiding treatment can lead to painful urethra infection in men and can cause reproductive complications in women – among other issues, for both genders.

“The United States continues to have the highest STD rates in the industrialized world,” said the executive director of the National Coalition of STD Directors, David Harvey.

“We are in the midst of an absolute STD public health crisis in this country. It’s a crisis that has been in the making for years,” he added.

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From The Editors Health

Russian Election Trolls Responsible for Spreading Vaccine Safety Disinformation

A study, published Thursday in the American Journal of Public Health, has revealed that the Russian propaganda machine was not only responsible for meddling in the 2016 U.S. Presidential election, it was also behind the vaccine-related tweets that fuelled a raging vaccine debate on social media at the time, creating doubts about the efficacy of vaccines in people’s minds.

The main purpose of the researchers at the George Washington University, in Wash DC, Johns Hopkins University, Baltimore, MD, and the University of Maryland, in College Park, MD, was to study the impact of social media on people’s thought processes when making vaccine-related decisions.

However, what they did find in their scrutiny of social media and survey data was that Twitter accounts run by Russian trolls, programmed bots, and, what the study authors call “content polluters,” masqueraded as genuine accounts on Twitter to influence public opinion on vaccination.

They systematically disseminated both pro- and anti-vaccine tweets, maliciously intended to cause discord and debates, their efforts not really going in vain as they did manage to “[erode] public consensus on vaccination.”

While content polluters (accounts that spread malware and unsolicited commercial content) disseminated 75 percent more anti-vaccine messages than the average Twitter user, Russian trolls were fanning the fire with supportive as well ant-vaccine tweets.

Meanwhile, unidentifiable accounts continued their polarization campaign, promoting anti-vaccine sentiments among users.

“The vast majority of Americans believe vaccines are safe and effective, but looking at Twitter gives the impression that there is a lot of debate,” said David Broniatowski – an assistant professor in the School of Engineering and Applied Science at George Washington University and the lead author of the study.

“It turns out that many anti-vaccine tweets come from accounts whose provenance is unclear. These might be bots, human users or ‘cyborgs’—hacked accounts that are sometimes taken over by bots. Although it’s impossible to know exactly how many tweets were generated by bots and trolls, our findings suggest that a significant portion of the online discourse about vaccines may be generated by malicious actors with a range of hidden agendas,” he added.

What became immediately apparent to the researchers was that the tweets seemed to be an attempt to “relate vaccines to issues in American discourse, like racial disparities or class disparities that are not traditionally associated with vaccination” – something which the researchers found “kind of weird,” says Broniatowski.

To emphasize his point, Broniatowski cited a particularly “weird” tweet, which, according to him said “something like ‘Only the elite get clean vaccines,’ which on its own seemed strange.”

And, weird it does sound, because anti-vaccine tweets should ideally portray vaccines as risky for everyone alike, rather than targeting a specific socioeconomic class, which the tweet seemed to be doing.

“These trolls seem to be using vaccination as a wedge issue, promoting discord in American society,” says Mark Dredze, one of the study co-authors from the Department of Computer Science, Whiting School of Engineering, John Hopkins University.

The study comes at a time when Europe is faced with one of the largest measles outbreak in decades, with 41,000 cases reported across the continent in only the first half of 2018.

24,000 cases of measles with 1,500 serious complications and 10 related deaths were reported in France between 2008 and 2016 – easy availability of the vaccine notwithstanding.

Declining vaccination rates fuelled by anti-vaccine movements is one of the major reasons for the loss of faith in vaccination among people, resulting in low immunity against communicable diseases.

To give you an idea of the kind of distrust of vaccines that exist among the French people, a survey involving 65,819 individuals across 67 countries revealed that 41% of the French people surveyed did not agree that “vaccines are safe,” when the global average is only 13 percent.

We are astonished to see that 41 percent of the French say they are wary of vaccinations,” said Dr. François Chast – Head of Pharmacology at Paris Hospital.

“It is urgent to fight the speeches of anti-science and anti-vaccination lobbies that play on fear, they show nothing and rely on a few very rare side effects to discredit vaccines that save millions of lives,” he added.

Professor Alain Fischer – president of a body that advises on vaccinations – said that the moment the subject of “vaccination obligation” comes up, it triggers a massive debate.

“Unfortunately there are no other solutions to combat the upsurge in childhood diseases. It is a short-term evil for a long-term good,” Fischer said.

Another major contributor to the apprehensions about vaccine safety has been the fake study by the disgraced doctor Andrew Wakefield who has been barred from practicing medicine in the UK.

His study, linking the MMR (measles, mumps, and rubella) vaccine to autism and bowel disease, published in the journal “The Lancet,” in 1998, was officially struck off the journal in light of a “fatal conflict of interest.”

Subsequent scientific studies were successful in disproving the mythical theory of Wakefield the quack.

The January and February records of 2017 show that out of the 79 cases of measles reported in France during the period, 50 cases were reported in the north-eastern region of Lorraine only, as confirmed by the European Centre for Disease Prevention and Control.

Italian expert on infectious diseases Alberto Giubilini believes that there is justification in holding the parents liable for not vaccinating their children.

“The benefits of vaccination in terms of protection from infectious disease outweigh the costs and risks of vaccination,” he observed. “For instance, the World Health Organisation estimates that between 2000 and 2015, measles vaccination prevented more than 20 million deaths.”

Broniatowski and his study co-authors are of the opinion that “directly confronting vaccine skeptics enables bots to legitimize the vaccine debate” and that further research is imperative to “determine how best to combat bot-driven content.”

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From The Editors Health

New York University to Make Tuition Free for All Medical Students – No Eligibility Criteria

In a bid to eliminate students’ debt burden, New York University’s School of Medicine has taken the onus of covering full tuition for all current, new, and future medical students – financial condition and academic aptitude notwithstanding.

Owing to the burgeoning cost of tuition, debt-ridden medical graduates are getting drawn more and more towards lucrative specializations, thereby creating a shortage of doctors in areas of research and primary care – a major cause for worry for concerned university officials.

The estimated $600 million scholarship burden on the medical school that comes with the landmark announcement is a small price to pay to address this critical area of concern plaguing the medical profession – thanks to the high cost of tuition and the resultant debt burden.

With a $100 million endowment from Home Depot founder Kenneth Langone and his wife, Elaine, NFU has already managed to raise $450 million – that’s three-fourths of the estimated target achieved.

With tuition becoming absolutely free, aspiring doctors will now be encouraged to pursue their medical aspirations absolutely stress-free, at least financially; no outstanding study loans to pressure them into chasing specializations they’d rather avoid if they had the financial freedom.

The announcement, which drew a thunderous applause from students, came on Thursday (August 16) at the medical school’s annual White Coat Ceremony, welcoming new medical students with white lab coats to mark their initiation into their M.D. program.

“A population as diverse as ours is best served by doctors from all walks of life, we believe, and aspiring physicians and surgeons should not be prevented from pursuing a career in medicine because of the prospect of overwhelming financial debt,” NYU School of Medicine Dean Robert Grossman said in a statement.

To give you an idea of the enormity of the student debt problem, 75 percent of doctors who passed out in 2017 had study debts to pay back, says the Association of American Medical Colleges (AAMC).

Up by 4 percent from the previous year, the average cost of tuition in private schools in the 2017-2018 school calendar was $59,605, which is as good as taken care of by the $55,018 scholarship cover the NYU is providing with immediate effect to all students – current and new.

AAMA stats also show that the average education debt of doctors currently graduating from private medical schools is over $200,000, a demoralizing burden that leaves aspiring physicians with no option but to go after high-paying specializations.

Many budding doctors who have a passion for research, community-based work, or general practice, even though they don’t pay as much as specialization does, are not able to realize their dreams because they have huge study loans to pay off.

“This decision recognizes a moral imperative that must be addressed, as institutions place an increasing debt burden on young people who aspire to become physicians,” Grossman, who is also the CEO of NYU Langone Health, told the New York Times.

The NYU’s School of Medicine is going a step further by agreeing to refund the current year’s tuition fees already paid by students.

“This is going to be a huge game-changer for us, for our students and for our patients,” Associate Dean for Admission and Financial Aid Dr. Rafael Rivera was quoted by the Wall Street Journal to have said.

While other schools have also done their bit to ease the burden of costly tuition students are saddled with, none comes even close to this latest NFU offering.

Columbia University’s Vagelos College of Physicians and Surgeons announced earlier this year that all students who met the eligibility criteria for financial assistance would study debt-free.

University of California’s David Geffen School of Medicine has proposed to cover in excess of 300 merit-based scholarships from 2012 to 2022

Some reactions on Twitter

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From The Editors Health

America’s Opioid and Heroin Epidemic

Substance abuse and addiction are destroying a good section of America’s youth.

While it is a big cause for concern in itself, what’s even more distressing is the rate at which the use of contraband substances, even prescription drugs for that matter, has grown in the last ten years, or so.

When it comes to heroin, its use among Americans has increased five times in the last decade, according to a 2017 study conducted by the Columbia University Mailman School of Public Health.

The study also shows an unmistakable connection between prescription opioids and heroin abuse.

It’s no secret that the misuse of opioids has been on the rise ever since these drugs became openly available as prescription medicines in the nineties when pharmaceutical companies shouted out from the rooftops that opioid-based pain relievers were non-addictive.

You don’t have to be a genius to work out that prescription opioid abusers are more likely to become heroin users, and ultimately addicts, than those who have never used or abused them.

Here’s an example of how continued misuse of prescription opioids can trigger a user’s transition to heroin:

Let’s say, your legal access to the drug stops for some reason, and you’re too deep into it to just forget about it; what do you do?

Well, in most cases users start looking for alternative fixes and sources of supply and end up using heroin.

What else could be more easily accessible than street heroin – an affordable and easily available option in most parts of the country?

But that’s just one part of the larger picture.

Heroin use and addiction are not just limited to prescription opioid users; it’s a far bigger problem than that, but before we delve a little bit more into it, let’s first understand the difference between substance abuse and addiction.

Substance Abuse

Substance abuse is, basically, an overwhelming desire to use increasing amounts of one or more substances from time to time, discontinuing which does not really cause any kind of withdrawal symptoms.

This can be anything from legal over-the-counter stuff like cigarettes and alcohol to legal prescription drugs such as methadone, oxycodone, and Zolpidem; from chemicals like inhalants to illegal drugs, including marijuana, meth, cocaine, and HEROIN – potentially, the most lethal of them all.

Drug dependence/addiction

Substance dependence or addiction, on the other hand, is the physical and psychological dependence on a drug for normal day to day functioning.

Discontinuation of the drug leads to withdrawal symptoms, which can range from mild to severe, depending on the drug the user is addicted to, including other factors like the amount of daily consumption and duration of use.

And, trust me, nothing can be more agonizing and devastating, both, mentally and physically, than the withdrawal symptoms of heroin – it truly is a nightmare.

Heroin use and addiction is a huge, complex problem – a clear and present danger in our society – that can’t be given the ostrich treatment.

It’s costing the economy a fortune; it’s related to lots of violent crime; and there’s no denying the fact that it’s destroying the country’s social fabric, not to mention deaths from substance and prescription opioid overdoses.

Drug abuse and addiction, specifically heroin addiction, is an all-encompassing issue with serious repercussions for users, including financial issues, social ostracization, decline in physical, mental and behavioral health, destroyed relationships, broken homes and even death in many cases.

So, what is heroin?

Heroin is an opioid, also known as diamorphine, diacetylmorphine, or morphine diacetate.

On the street, it is referred to by various names, including smack, junk, brown, dope, horse and H, to name a few.

Managing the withdrawal state of heroin addicts requires a different set of drugs compared to those used for alcohol, cocaine and other substance withdrawals.

Naloxone (Narcan)

Sold under the brand name Narcan, among others, Naloxone is an effective medication used in treating heroin withdrawal symptoms and overdose cases.

Naloxone can be injected intravenously or into the muscle, each with a different reaction time, which can be as quick as two minutes when injected intravenously compared to the five minutes it takes to work when injected into the muscle.

It can also be administered subcutaneously (under the skin) or as a nasal spray.

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Naloxone is an FDA-approved drug and by virtue of being on the World Health Organization’s List of Essential Medicines, it can be considered safe and effective.

In addition to Narcan, other brand names that Naloxone is sold under include Nalone, Evzio, Prenoxad Injection, Narcanti, and Narcotan, among others.

While Naloxone is a legal prescription drug, rules governing its dispensation by doctors and licensed professionals can vary from state to state.

However, so safe is Naloxone that as many as 37 states in the country allow the over-the-counter purchase of the drug from pharmacists, without the need for a doctor’s prescription.

Again, the safety and efficacy of the drug are evident from the fact that law enforcement agencies in 25 states are legally permitted to carry Naloxone when responding to opioid overdose calls, especially useful when they reach a location before the paramedics do.

It can and does save lives.

Naloxone and other medication are all very good in so far as alleviating the effects of heroin overdose and withdrawal symptoms are concerned, but it’s not the answer to addiction – far from it, in fact.

Self-help recovery

While there are different medicines and treatment for abuse of different substances, when it comes to self-help recovery it’s, more or less, the same general strategies, no matter what the substance in question is.

These strategies also apply to non-substance addictions like self-mutilation, eating disorders, gambling, and sex addiction.

It has been observed that in most cases of substance abuse the problem is not really the problem; it’s what the user, consciously or subconsciously, thinks is the solution to a bigger problem.

If you’re addicted to cutting yourself, for example, it is, in all likelihood, because of some bad feelings, bad situations, or conflicts – basically stuff you don’t want to deal with.

So, you get a razor blade and slash your wrist and voila – instant euphoria, not different from a shot of heroin.

Gone are the feelings of despondency and doom, replaced by a feeling of calm; a sense of power, control, and hopefulness; life becomes much more tolerable.

However, the reinforced feeling that the self-mutilation brings about is short-lived and before you know it all those negative feelings are back, forcing you to repeat the dose.

It’s the same with heroin; the only difference is that when the effects of heroin start to wear off, not only does the negativity return with a vengeance, it also brings with it extreme physical and mental discomfort.

Self-help recovery techniques require you to take a step back and ask yourself some hard questions.

Why am I doing this? Is it solving a problem? What is that problem?
Some people are under the misconception that addicts are weak; well, nothing could be further from the truth.

It’s just a disease that can be controlled, if not treated.

Do you think they just woke up one fine morning and voluntarily decided to become an addict who has to steal every day for a fix?

It could be an underlying problem that can be traced back to your childhood, your teen years, or your adulthood – probably some bad feelings, bad situations, bad relationships, a bleak picture of the future, or whatever.

God, it’s too much; I can’t deal with it; and before you know it you’re cutting yourself, indulging in random and unsafe sex, eating excessively, getting stoned, or getting wasted on heroin.

It all boils down to identifying what it is that you’re trying to cope with and then deciding on what you’re going to do about it in a healthy way so you can eventually let go of your addiction to whatever it is you seek relief in.

Self-inventory plays a huge role in self-help recovery and the first step towards that is to accept that you have a problem – and a big one at that – because all this while you were in denial that you had a problem – a problem not beyond solving.

The level of denial among addicts can be astounding and, more often than not, acceptance does not set in until a major disaster happens.

Continued denial is, generally, a measure of the addict’s desperation to avoid the real pain – the underlying cause of the addiction.

There is no fixed formula, method, or strategy for self-help recovery – it’s a matter of what works for you and what motivates you.

Alright, so it’s easier said than done, but the key is to be motivated enough and not be in denial.

The desire to rehabilitate should come from within; it’s not something that can be force-fed.

However, it is still something that can be encouraged with the right kind of professional help, peer support and, most importantly, a lot of patience, love and understanding on the home front.

Trafficking and distribution

How does heroin reach the U.S. borders and eventually the nation’s streets? How much smack are we talking about?

There’s a common misconception that most of the heroin coming into the U.S. is being trafficked through Central America’s “Northern Triangle” region.

Assistant Secretary of State for International Narcotics Control and Law Enforcement Affairs William Brownfield estimates that 90-94 percent of all heroin consumed in the United States comes from Mexico, about 2 to 4 percent from Columbia, while the remaining 4 to 6 percent comes from Asia – a large part of it originating in Afghanistan.

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Although Afghanistan doesn’t have much of a say in the US heroin scene, it is responsible for most of the drug consumed elsewhere in the world, producing about 80 percent of the world’s heroin.

After the heroin finds its way into the U.S., how does it trickle down to street level dealers selling the H in nickel bags?

Although the method of illegal drug sales and distribution follows a pretty much generic pattern involving retail level distributors and wholesale distributors, it can be extremely complex when applied to specific distribution groups, according to a study.

The holders, transporters, mules, deliverers, counters, lookouts, backups, muscle, and whatever else it takes, make up the distribution network that operates like a well-oiled machine to make the poison available on street corners, neighborhoods and around educational institutions and wherever else it can be pedaled.

This is big business we’re talking about and, like it or not, it seems like it’s not going to go away anytime soon.

How do other countries deal with this menace?

The U.S. is one of the smartest and strongest countries in the world, yet you have drug dealers running rampant in the cities and towns, killing children and destroying families.

It’s the United States of America, for God’s sake!

Despite the efforts of the DEA and other law enforcement agencies, the drug menace continues unabated in the U.S.

How come countries like China, Saudi Arabia, Thailand, and Singapore, among others, are better off when it comes to controlling drugs and addiction?

The answer to that is simple; their drug laws are strict enough to work as effective deterrents.

In short, put the fear of God in the hearts of perpetrators, and you’ll have better control of the drug situation.

In China, if you are caught with drugs you’re made to attend a state-run drug rehab facility, with some drug crimes even attracting the death penalty.

Saudi Arabia is among the strictest of countries when it comes to drug laws; selling drugs in the Kingdom almost always attracts the death penalty.

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Even alcohol is illegal in this Islamic nation and possession or use of alcohol or drugs is punishable by public flogging, financial penalties, lengthy imprisonment, or death.

In Thailand, traffickers can get the death penalty, while users are generally required to go through a government-sponsored mandatory rehab program.

In Singapore, even if you are caught with a relatively small amount of drugs, the police will, by default, treat you as a seller, which, if proved, will lead to the death sentence.

What more can be done in the U.S?

The DEA is constantly devising new plans and strategies to curb the influx of heroin and its distribution networks working in the country.

With more than 90 percent of heroin coming in from Mexico, the DEA, of late, has included more technology in its battle against Mexican heroin, using drone and geo-location technologies to identify Mexican farms cultivating poppy – the raw material for producing heroin.

However, not much is expected from this endeavor because attacking the problem in one location causes a balloon effect, meaning the cultivation shifts to another area, former DEA official Mike Vigil told NPR’s Lulu Garcia-Navarro, as recently as April, this year.

This is one of the reasons why Donald Trump is pushing so hard for the wall.

Cutting the proverbial head of the snake sounds like the ideal solution, but what do you do with a monster of epic proportions with several heads?

This is where the common man – the concerned citizen – can have a role to play, even if it’s only by way of creating awareness and making contributions to non-profit organizations who are genuinely working towards a common cause – a drug-free America.

As far as lawmakers are concerned, it’s about time they took a leaf out of the China or Saudi Arabia book, and put strict legislation in place that can serve as a powerful deterrent.

Categories
From The Editors Health

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

The United States Food and Drug Administration (FDA) on Friday (August 10) gave its nod of approval for the marketing of a Swedish App called Natural Cycles as a tech-based method of contraception in the country.

While the app has been in use in the European Union ever since it was certified by the concerned European organization for inspection and certification in February last year, it is the first time an app-based form of contraception has been approved for use in the U.S.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” said Terri Cornelison – assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.

“But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she warned.

Welcoming the FDA clearance, the Stockholm-based company tweeted:
“We are delighted that the US Food and Drug Administration (FDA) has cleared Natural Cycles as the first digital method of birth control in the US #contraception #FDA.”

The Natural Cycles app will be available to subscribers at an annual fee of about $80 and will include a basal thermometer for the user to take a temperature reading immediately upon waking up each morning and logging it in the app.

A basal thermometer is more sensitive and accurate as opposed to a regular fever thermometer, in that it displays the readings with two decimal places.

Based on menstrual cycle information and early morning temperature inputs by women, the app uses an algorithm to determine the fertility of the user on a given day and then flags it as a fertile or infertile day, depending on the calculations.

A red day indicates that the user is fertile, which means having unprotected sex on a red-flagged day would likely result in pregnancy.

It then depends on the user to abstain from sex on red days or use a contraceptive – or just go for it if the user is actually looking to get pregnant – no better day than a red day for that.

Conversely, a green day would mean the user is infertile and indulging in sexual intercourse on such a day definitely reduces the risk of conception but does not eliminate it altogether, as already mentioned.

More than 15,000 women were made to use the app for a period of eight months as part of a clinical study to determine the effectiveness of Natural Cycles as a method of birth control.

The findings revealed that “the app had a “perfect use” failure rate of 1.8 percent, which means 1.8 in 100 women who use the app for one year will become pregnant because they had sexual intercourse on a day when the app predicted they would not be fertile or because their contraceptive method failed when they had intercourse on a fertile day,” the FDA explains.

“The app had a “typical use” failure rate of 6.5 percent, which accounted for women sometimes not using the app correctly by, for example, having unprotected intercourse on fertile days,” says the agency.

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

Out of 668 women who underwent abortions at a Stockholm hospital between September and December 2017, 38 of them had been using the Natural Cycles app, necessitating an investigation by the country’s Medical Products Agency, which is currently ongoing and expected to last until September.

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,” said an ASA spokesman.

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,” reports the Guardian.

A U.K. charity known as The Family Planning Association told the Guardian that Natural Cycles’ claims to contraception is a cause for concern.

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.

“An increase in the absolute numbers of unintended pregnancies is expected with a growing number of users,” VICE News quoted Kotz as saying.

“We reached out to the Swedish authorities and feel that the information regarding the pregnancies in Sweden is consistent with our knowledge concerning the pregnancy risks associated with the use of this device,” she said.

“We are in contact with the ASA and, since the investigation is ongoing, it would not be appropriate for us to speculate on the outcome,” The Guardian quoted a Natural Cycles spokeswoman to have said.

“We can confirm however, that the ASA complaint in relation to the Facebook advertisement in question was actually raised in 2017.

“The advertisement which only ran for a few weeks has been taken out of circulation and we have accepted the draft recommendations very recently shared with us by the ASA,” she said.