Video of father comforting newborn son receiving his first vaccines goes viral

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On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, he also continually reassured his son that he could cry if he needed to.

TEARS AS CONJOINED TWINS DIE DAY AFTER BIRTH

When it came time for the vaccinations, Lee held his son in his arms and told the little boy to “stay strong,” while Shamekia Harris, Lee’s girlfriend, recorded the visit on her phone. Little Debias did cry as the nurse gave him his shots, but stopped soon afterward when Lee consoled him.

The video has since gone viral, with about 13 million views, 51 thousand likes, and 186 thousand shares as of Wednesday.

Sadly, Lee’s father, Anthony Lee, 57, died that same day due to complications from drinking. Lee explained to People that he was emotional and very close to his father, and that he later spoke to his son Debias about his hopes for the future.

“I talked to him like a grown up … I told him, before I leave, want to see him succeed,” Lee said.

Lee wishes that the video will remind others of the importance of fatherhood, “I want them to take care of their kids, because when you sign up for something, you have to stick with it,” he told People.

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Lee, however, isn’t the only person to go viral for his vaccination video: In 2014, pediatrician Michael Darden gained attention for his unique approach to giving shots, and the video still doesn’t disappoint:

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IT’S A NO BRAINER! Action needed to stop children being exposed to chemicals that harm their brain development!

A report published today by CHEM Trust highlights how chemicals in food and consumer products used in homes, schools and offices could harm brain development in children.

The impacts – which may include ADHD and lower IQ – are avoidable and can prevent children reaching their full potential says CHEM Trust, in No Brainer: The impact of chemicals on children’s brain development: a cause for concern and a need for action.

Researchers have shown that many thousands of people have been exposed to now largely-banned chemicals such as lead and PCBs at high enough levels to have harmed their brain function. Now there is growing concern about the impacts of exposures to many of the ‘new’ chemicals in our 21st century lifestyles.

Chemicals of concern include brominated flame retardants (BFRs), a group of chemicals added to furniture, electronics and building materials, per- and poly- fluorocarbons (PFCs), used for non-stick coatings or breathable coatings in everyday products including packaging and clothes. Some chemicals in these groups are being phased out, but similar chemicals remain in everyday use.

The study also points out the unpleasant reality that children are constantly exposed to a cocktail of chemicals, which can act together, something which is still largely ignored by chemical safety laws.

CHEM Trust proposes a range of policies that could help address this challenge, for example faster regulatory action on groups of similar chemicals, and development of new methods for identifying chemicals of concern. They also include advice for consumers on how to reduce their exposure.

Dr Michael Warhurst, Executive Director of CHEM Trust, said:

“The brain development of future generations is at stake. We need EU regulators to phase out groups of chemicals of concern, rather than slowly restricting one chemical at a time. We cannot continue to gamble with our children’s health.”

The report has been peer reviewed by two eminent scientists in the field, Professor Philippe Grandjean and Professor Barbara Demeneix.

Prof Barbara Demeneix (Laboratory of Evolution of Endocrine Regulations, CNRS, Paris) said:

Chemical exposure is now at unprecedented levels, is multiple, ubiquitous, and present from conception onwards

Prof. Philippe Grandjean (Department of Environmental Medicine, University of Southern Denmark), added:

The current generation has the responsibility to safeguard the brains of the future
“I would insist that the Precautionary Principle must be applied in order to protect the next generation’s brains.”

 

Read More: http://snip.ly/maoou#http://www.chemtrust.org/brain/

 

The science of Sad: understanding the causes of ‘winter depression’

The science of Sad

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.

In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

Putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

The most popular treatments for Sad is bright-light therapy.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder

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The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAAThe use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

  1. Process Design
  2. Process Qualification
  • Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.

The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.

The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.

Thorough understanding of how to implement Applied Statistics for FDA Process Validation

GMPs for Combination Products and 505(b)(2) Products

The ways of using Applied Statistics for FDA Process Validation will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. At this seminar, Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director.

Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901132SEMINAR?wordpress-SEO to register for this meaningful and highly valuable seminar on applied statistics for process validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A methodical approach to implementing statistical methodologies

Top 20 Costly Mistakes

The focus of this two-day course on Applied Statistics for FDA Process Validation is the various ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Dr. Burdick will begin with a primer on statistics, where he will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.

The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Since the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

The aim of this learning on Applied Statistics for FDA Process Validation is to lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

Complete learning on Applied Statistics for FDA Process Validation

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Over the two days of this seminar, the participants will learn how to:

  • Apply statistics for setting specifications
  • Assess measurement systems (assays)
  • Use Design of Experiments (DOE)
  • Develop a control plan as part of a risk management strategy, and
  • Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

  • Apply statistics to set specifications and validate measurement systems (assays)
  • Develop appropriate sample plans based on confidence and power
  • Implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

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Second Death From Flesh-Eating-Bacteria Infection After Hurricane Harvey Is Reported

 

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.

He is the second person to die from flesh-eating bacteria since Hurricane Harvey struck the Gulf Coast. Two weeks ago, a 77 year old woman died after a fall inside her flooded home in which she cut her arm and subsequently contracted the flesh-eating bacteria.

When the man initially presented to the hospital on October 10th, officials described an infected wound affecting the upper portion of his left arm.

The aggressive and deadly soft tissue infection is formally referred to as necrotizing fasciitis . It’s a rare infection under normal circumstances, but if promptly recognized, diagnosed and treated with the appropriate antibiotics and surgery to remove dead or dying tissue, the majority of patients recover without any serious consequences.

Necrotizing fasciitis, or “nec fasc”, is most commonly caused by Group A Strep , but a mixed infection with anaerobic bacteria including Clostridium may also develop, leading to what is commonly known as gas gangrene. Necrotizing fasciitis causes pain out of proportion in the affected area, relative to the degree of injury.

A cut, scrape, puncture or any break in the skin may serve as a portal of entry for the dangerous bacteria, which then leads to destruction of blood vessels, fat, nerves and a white fibrous covering of the muscle known as the fascia. The infection then proceeds to enter the muscle, compromising blood flow and leading to death of the tissue.

Its important to realize that bacteria don’t actually digest the tissue, but instead produce a deadly toxin that is responsible for the extensive tissue damage.

As the bacteria enter the bloodstream, fever, chills and vomiting may rapidly develop, leading to a dangerous condition known as sepsis which is characterized by low blood pressure, rapid and difficult breathing and confusion.

Early warning signs include severe pain and tenderness in the infected area, spreading redness and warmth and blue to purple skin discoloration, with darkened tissue in the later stages. The presence of gas or air in the soft tissue known as “crepitus” produces a crackling sound or crunching sensation if the area of skin is palpated. An abscess containing pus may also form as the infection becomes more organized.

Necrotizing fasciitis is a surgical emergency. Aggressive fluid resuscitation along with broad spectrum antibiotics must be started promptly with emergent preparation for surgery to remove or debride the affected area in order to contain the infection.

Persons with diabetes, chronic kidney disease and cancer who are receiving chemotherapy are most at risk for complications, due to poor blood supply to skin, muscle and soft tissue from having such chronic conditions.

Flood waters harboring bacteria (from sewage), along with dirty surfaces or debris contacting the victim’s initial cut or injury, likely led to the onset of this aggressive and deadly infection. As a general rule, it’s best to keep all cuts or blisters covered with a dry gauze and waterproof type dressing if there is any potential to come in contact with floodwater or dirty surfaces or debris.

The CDC describes about 700-1,110 cases annually in the U.S., the result of an active surveillance and reporting network that is set up to monitor such aggressive infections.

Cases of typhoid and cholera, invasive and aggressive diarrheal illnesses typically associated with floods in developing countries, never materialized after the hurricane, according to data from the CDC. In addition, cases of tetanus, which can develop from heavily contaminated wounds after soil exposure, have generally not been a concern with such flooding in the U.S., as supported by data from the CDC.

“Necrotizing fasciitis is caused by strep group A (flesh-eating bacteria) or anaerobic bacteria which thrive in areas without oxygen,” said Debra Spicehandler, MD, Co-Chief of Infectious Diseases, Northern Westchester Hospital.  ”Antibiotics are important but swift surgical debridement is necessary. The cases caused by strep release a toxin which can also cause systemic effects and organ failure leading to mortality.”

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Heart surgery survival chances ‘better in the afternoon’

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Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.

The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.

And it says the difference is not down to surgeons being tired in the morning.

Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.

The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

  • 54 out of 298 morning patients had adverse events
  • 28 out of 298 afternoon patients had adverse events
  • Afternoon patients had around half the risk of complications
  • One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”

He also said it would be impossible for hospitals to conduct surgery only after lunch.

But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”

Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.

Heart health is already known to fluctuate over the course of a day.

The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

 The risk of a heart attac.jpg

Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.

“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.

Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

Forbes Talks Taxes, Healthcare in Address to Students

Forbes Talks Taxes, Healthcare in Address to Students

As Republicans struggle to score a legislative win on taxes, Steve Forbes dismissed fears that the American economy is doomed to slow economic growth or secular stagnation as “preposterous.”

Forbes, the chairman and editor-in-chief of Forbes Media and former Republican presidential candidate, blamed the current economic rut on correctable policy errors in a lecture sponsored by the Cornell Republicans on Wednesday.

The real source of wealth in society derives not from physical things, Forbes said, but from the human mind, as the modern economy cannot prosper without “human ingenuity.” Free markets will always turn scarcity into abundance, he said, using automobile innovation as an example.

“One hundred twenty years ago, a car costed over 110,000 dollars,” he said. “It was a toy for the rich. But Henry Ford came along with the moving assembly line and turned this toy for the rich into something every working person can afford.”

Rejecting the argument that automation will deprive Americans of jobs, Forbes said that free markets will allow people to apply ingenuity and advance a society built on knowledge and innovation.

The fear of robots, he said, is misguided, since society has been utilizing robots throughout history. He urged students to think about how the invention of the tractor — which was viewed as a robot when it was first introduced — freed up millions of acres for farmland and hours of labor.

Forbes also said that Republicans are unable to pass a tax cut because they are putting “process before progress,” and relying too heavily on the Congressional Budget Office to predict the future to change various laws and tax codes.

“The blunt truth is, if the Congressional Budget Office knew what would happen, they would be buying lottery tickets or speculating commodities,” he said.

Forbes proposed that Republicans follow the actions of Ronald Reagan and pursue a straight tax cut, which he said would reduce the business tax rate to 15 percent.

Republicans led on cuts to healthcare rather than taxes primarily because the CBO calculated that the government would save $1.1 trillion over the next 10 years following healthcare cuts, which would ultimately allow for additional tax cuts, Forbes said. However, the plan to cut healthcare and then follow up with cuts to larger company’s tax bills is an unfortunate message to the American people, he said.

Forbes also criticized the federal income tax code, calling it a “monstrosity” that not even experts in the Internal Revenue Service truly understand.

“Take this monster,” he said, referring to the federal income tax code. “I would say bury it, but I don’t know if the EPA would let us bury something so toxic.”

The problem with the American healthcare system stems from the lack of real free markets, Forbes said. There is a disconnect between providers and consumers, since the system is controlled by insurance companies, rather than by the patient. Hospitals’ revenues depend on negotiations with insurers and the government, but not with satisfying patients, he said.

“The crummiest motel in America wouldn’t dare put you in a room with another guest with a curtain in between,” he said. “But they do it routinely in hospitals.”

Nationwide “shopping” for health insurance, equal tax treatment and increased transparency between hospitals and patients are all factors key to improving the healthcare system, Forbes said.

Hospitals should also be mandated to publicly post how many patients die from infections they have received after admission to the hospital, he said.

“Ninety thousand patients die from infections after being admitted to hospitals,” he said. “Experts say 80 percent of these deaths could be prevented.”

 

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