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THE NUREMBERG CODE AND ITS IMPACT ON CLINICAL RESEARCH

Posted by Natalie Jarmusik on Tue, Apr 9, 2019
Source: IMA Research

Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects. 

What Is the Nuremberg Code?

When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945.  As part of the Tribunal, a series of trials were held against major war criminals and Nazi sympathizers holding leadership positions in political, military, and economic areas.  The first trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious experiments they carried out on unwilling prisoners of war.  Many of the grotesque medical experiments took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after death.

The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was conducted at the Palace of Justice in Nuremberg, Bavaria, Germany.  The trial was conducted here because this was one of the few largely undamaged buildings that remained intact from extensive Allied bombing during the war.  It is also said to have been symbolically chosen because it was the ceremonial birthplace of the Nazi Party.  Of the 23 defendants, 16 were found guilty, of which seven received death sentences and nine received prison sentences ranging from 10 years to life imprisonment. The other 7 defendants were acquitted. 

The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for human experimentation. 

What Are The Nuremberg Code’s Ethical Guidelines For Research?

The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are: 

  1. Voluntary consent is essential
  2. The results of any experiment must be for the greater good of society
  3. Human experiments should be based on previous animal experimentation
  4. Experiments should be conducted by avoiding physical/mental suffering and injury
  5. No experiments should be conducted if it is believed to cause death/disability
  6. The risks should never exceed the benefits
  7. Adequate facilities should be used to protect subjects
  8. Experiments should be conducted only by qualified scientists
  9. Subjects should be able to end their participation at any time
  10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur

Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

The History of Clinical Research Timeline by IMARC Research

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Source: IMA Research
Shidonna Raven Garden and Cook

The Significance Of The Nuremberg Code

The Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP)

Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts, ideas and lessons learned throughout the history of clinical research worldwide.

Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule. 

Although there has been updated guidance to Good Clinical Practice to reflect new trends and technologies, such as electronic signatures, these basic principles remain the same. The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects. 

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6 Science-Based Health Benefits of Oregano

Source: Healthline
Oregano is considered a staple herb in many cuisines around the world.

It has a strong flavor and brings warmth to dishes, along with a hint of subtle sweetness.

It can be found fresh, dried or as an oil, and all are said to have significant health benefits.

Though typically used in small amounts, oregano packs in some important nutrients. Just one teaspoon of dried oregano can fulfill about 8% of your daily vitamin K needs (1).

From helping fight bacteria to reducing inflammation, studies have unearthed some of its impressive potential benefits.

This article looks at 6 evidence-based health benefits of oregano.

1. Rich in Antioxidants

Source: Healthline
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Oregano is rich in antioxidants, which are compounds that help fight damage from harmful free radicals in the body.

The buildup of free radicals has been linked to chronic diseases like cancer and heart disease (2Trusted Source3Trusted Source).

Several test-tube studies have found that oregano and oregano oil are high in antioxidants (4Trusted Source5Trusted Source).

Oregano essential oil is especially high in carvacrol and thymol, two antioxidants that can help prevent damage to cells caused by free radicals (6Trusted Source).

In combination with other high-antioxidant foods like fruits and vegetables, oregano could provide a hearty dose of antioxidants that may help improve your health.

SUMMARY: Oregano is high in antioxidants, which can help prevent damage by neutralizing disease-causing free radicals.

2. May Help Fight Bacteria

Oregano contains certain compounds that have potent antibacterial properties.

One test-tube study showed that oregano essential oil helped block the growth of Escherichia coli and Pseudomonas aeruginosa, two strains of bacteria that can cause infection (7Trusted Source).

Another test-tube study found that oregano was effective against 23 species of bacteria (8Trusted Source).

Furthermore, a test-tube study compared the antimicrobial activity of oregano, sage and thyme essential oils. Oregano was one of the most efficient essential oils against bacteria, second to thyme (9Trusted Source).

Current research is limited to test-tube studies that have used concentrated amounts of this herb. Thus, further research is needed to determine how these results could affect humans.

SUMMARY: Test-tube studies have found that oregano and its components may be effective against certain strains of bacteria.

Oregano is high in antioxidants. These compounds can not only neutralize free radical damage, but they may also aid in cancer prevention (2Trusted Source).

Some test-tube studies have shown that oregano and its components may help kill cancer cells.

One test-tube study treated human colon cancer cells with oregano extract and found that it stopped the growth of cancer cells and helped kill them off (10Trusted Source).

Another test-tube study showed that carvacrol, one of the components in oregano, also helped suppress the growth and spread of colon cancer cells (11Trusted Source).

However, keep in mind that these were test-tube studies using high amounts of the herb and its compounds. Human studies using typical doses are needed to determine its effects.

SUMMARY: Oregano is high in antioxidants and contains compounds that have been shown to reduce cancer cell growth in some test-tube studies.

4. May Help Reduce Viral Infection

In addition to fighting off bacteria, some test-tube studies have found that oregano and its components may also protect against some viruses.

In particular, carvacrol and thymol are two compounds in oregano that have been associated with antiviral properties.

In one test-tube study, carvacrol inactivated norovirus, a viral infection that causes diarrhea, nausea and stomach pain, within one hour of treatment (12Trusted Source).

Another test-tube study found that thymol and carvacrol inactivated 90% of the herpes simplex virus within just one hour (13Trusted Source).

While these results are promising, additional research on how oregano may impact viral infections in humans is needed.

SUMMARY: Carvacrol and thymol are two compounds found in oregano that have been shown to decrease the activity of viruses in some test-tube studies.

5. Could Decrease Inflammation

Inflammation is a normal immune response that occurs as a result of illness or injury.

However, chronic inflammation is believed to contribute to the development of diseases like heart disease, diabetes and autoimmune conditions (14Trusted Source).

Oregano is rich in antioxidants, which can help neutralize free radicals and reduce inflammation (15Trusted Source).

It also contains compounds like carvacrol that have been shown to have anti-inflammatory properties. In one animal study, carvacrol reduced swelling in the paws of mice by up to 57% (16Trusted Source).

Another animal study showed that a mixture of thyme and oregano essential oils reduced the number of inflammatory markers in mice with colitis, or an inflamed colon (17Trusted Source).

Remember that these studies looked at the effects of oregano and its components in highly concentrated amounts. Studies are needed to determine how a normal dose could affect inflammation in humans.

SUMMARY: Oregano is high in antioxidants, which may reduce inflammation. Animal studies show that oregano oil and its components could help reduce inflammation.

6. Easy to Add to Your Diet

Though you may think of oregano as a topping reserved solely for pizzas and pasta dishes, this versatile herb can be used in many ways.

Try mixing whole oregano leaves into other greens for a nutrient-packed salad or sprinkling the leaves into chili, soups or stews.

You can also use it to make fresh pesto or salad dressing, season meat dishes or kick up the flavor of homemade sauces.

Oregano is available fresh, dried or as an oil, making it super easy to add to your diet.

SUMMARY: Oregano is available either fresh, dried or as an oil, and it can be added to stews, dressings, sauces, meats and more.

The Bottom Line

Oregano is an herb that boasts some pretty potent benefits when it comes to your health.

It is high in antioxidants and may help fight off bacteria and viruses, potentially reduce the growth of cancer cells and help alleviate inflammation.

However, current research is limited to test-tube and animal studies. Further research is needed to determine its potential effects in humans.

Luckily, oregano is versatile, easy to add to your diet and can be incorporated into a wide variety of recipes in either fresh, dried or oil form.

Try our Red Rosemary Shrimp Pasta as a way of adding Oregano to your diet. How can oregano address your health and diet needs? What medicinal benefits are beneficial to you? What other herbs might you add to your diet?

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Medical device recalls rise 31% in Q2

Medical Device Shidonna Raven Garden and Cook

Maia Anderson – Thursday, August 27th, 2020 
Source: Beckers Hospital Review
Feature Photo Source: Unsplash, Owen-Beard

The number of medical device recalls has increased 31.2 percent in the second quarter of 2020, according to Stericycle’s Q2 recall index

The total number of recalls in the second quarter was 341, surpassing 300 for the first time in two years. While the average recall size was lower than the first quarter, the number of recalls  puts the medical device industry on track for 1,200 recalls by the end of the year, which would be an annual increase of 35 percent over 2019. 

The number also doesn’t include unofficial recalls of face masks and other personal protective equipment handled at the state level. 

For the first time in 16 consecutive quarters, safety issues accounted for 48 recalls, or 14.1 percent, of all the recalls in the second quarter, overtaking software issues. But cyberattacks targeting health systems, hospitals and healthcare organizations are still on the rise, and connected medical devices are vulnerable, according to the report. 

Sterilization issues affected the most units, accounting for 62.9 percent of recalled units. 

Out of all of the recalls, 83.3 percent affected products that were distributed nationwide, and 48.4 percent affected products distributed internationally. 

Find the full report here

What do you think of the rise of medical devices in the context of robotics, Ai and cyborgs? What do you think of the rise of the medical devices in the context of the pandemic and commercial space travel? What do you think of the rise of the medical device industry in the context of Elon Musk’s goal of building a city in Mars by 2050? Why?

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‘Cyborg’ technology could enable new diagnostics, merger of humans and AI

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Date: August 17, 2020
Source: American Chemical Society
Feature Photo Source: Unsplash, thisisengineering


Summary: Although true ‘cyborgs’ are science fiction, researchers are moving toward integrating electronics with the body. Such devices could monitor tumors or replace damaged tissues. But connecting electronics directly to human tissues in the body is a huge challenge. Today, a team is reporting new coatings for components that could help them more easily fit into this environment.


Although true “cyborgs” — part human, part robotic beings — are science fiction, researchers are taking steps toward integrating electronics with the body. Such devices could monitor for tumor development or stand in for damaged tissues. But connecting electronics directly to human tissues in the body is a huge challenge. Now, a team is reporting new coatings for components that could help them more easily fit into this environment.

The researchers will present their results today at the American Chemical Society (ACS) Fall 2020 Virtual Meeting & Expo. 

“We got the idea for this project because we were trying to interface rigid, inorganic microelectrodes with the brain, but brains are made out of organic, salty, live materials,” says David Martin, Ph.D., who led the study. “It wasn’t working well, so we thought there must be a better way.”

Traditional microelectronic materials, such as silicon, gold, stainless steel and iridium, cause scarring when implanted. For applications in muscle or brain tissue, electrical signals need to flow for them to operate properly, but scars interrupt this activity. The researchers reasoned that a coating could help.

“We started looking at organic electronic materials like conjugated polymers that were being used in non-biological devices,” says Martin, who is at the University of Delaware. “We found a chemically stable example that was sold commercially as an antistatic coating for electronic displays.” After testing, the researchers found that the polymer had the properties necessary for interfacing hardware and human tissue.

“These conjugated polymers are electrically active, but they are also ionically active,” Martin says. “Counter ions give them the charge they need so when they are in operation, both electrons and ions are moving around.” The polymer, known as poly(3,4-ethylenedioxythiophene) or PEDOT, dramatically improved the performance of medical implants by lowering their impedance two to three orders of magnitude, thus increasing signal quality and battery lifetime in patients.

Martin has since determined how to specialize the polymer, putting different functional groups on PEDOT. Adding a carboxylic acid, aldehyde or maleimide substituent to the ethylenedioxythiophene (EDOT) monomer gives the researchers the versatility to create polymers with a variety of functions.

“The maleimide is particularly powerful because we can do click chemistry substitutions to make functionalized polymers and biopolymers,” Martin says. Mixing unsubstituted monomer with the maleimide-substituted version results in a material with many locations where the team can attach peptides, antibodies or DNA. “Name your favorite biomolecule, and you can in principle make a PEDOT film that has whatever biofunctional group you might be interested in,” he says.

Most recently, Martin’s group created a PEDOT film with an antibody for vascular endothelial growth factor (VEGF) attached. VEGF stimulates blood vessel growth after injury, and tumors hijack this protein to increase their blood supply. The polymer that the team developed could act as a sensor to detect overexpression of VEGF and thus early stages of disease, among other potential applications.

Other functionalized polymers have neurotransmitters on them, and these films could help sense or treat brain or nervous system disorders. So far, the team has made a polymer with dopamine, which plays a role in addictive behaviors, as well as dopamine-functionalized variants of the EDOT monomer. Martin says these biological-synthetic hybrid materials might someday be useful in merging artificial intelligence with the human brain.

Ultimately, Martin says, his dream is to be able to tailor how these materials deposit on a surface and then to put them in tissue in a living organism. “The ability to do the polymerization in a controlled way inside a living organism would be fascinating.”

What are your thoughts on cyborgs? What are your thoughts on cyborgs within the context of the pandemic? Do you think Elon Musk is correct, we are already cyborgs or do you think scientists can create cyborgs?

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‘If you can’t beat them join them’: Elon Musk says our best hope for competing with AI is becoming better cyborgs

Source: Business Insider
Graham Rapier Aug 29, 2019, 11:08 AM

Tesla Inc CEO Elon Musk and Alibaba Group Holding Ltd Executive Chairman Jack Ma attend the World Artificial Intelligence Conference (WAIC) in Shanghai, China, August 29, 2019. REUTERS/Aly Song
Source: Business Insider
Tesla Inc CEO Musk and Alibaba Group Holding Ltd Executive Chairman Ma attend the World Artificial Intelligence Conference in Shanghai 
Shidonna Raven Garden and Cook
  • Elon Musk talked artificial intelligence with Alibaba chairman Jack Ma in Shanghai on Thursday. 
  • Musk doubled down on his previous warnings that AI will overtake human intelligence
  • The Tesla CEO also took the time to mention his latest bet, Neuralink, and its planned brain-computer interface that could let human compete with AI. 

Elon Musk was in China on Thursday, but not to talk Tesla and its new factory in the country.

Instead, the chief executive talked artificial intelligence on stage next to Alibaba founder Jack Ma, and doubled down on his warnings that the technology could pose grave risks to human society as we know it.

“Generally, people underestimate the capability of AI,” Musk said at the conference in Shanghai. “They sort of think it’s like a smart human, but it’s going to be much more than that. It’ll be much smarter than the smartest human.”

Musk’s proposed solution: “If you can’t beat ’em, join ’em.

Amid the myriad of Musk’s corporate bets, one of the more recent endeavors is “Neuralink.” Unveiled in a white paper in July, the company hopes to begin testing its computer-brain interface in humans as early as next year. Experts say the technology is impressive, but called the timeline “delusional.”

“We are already a cyborg,” Musk said. “People don’t realize — we are already a cyborg because we are so well integrated with our phones and our computers. The phone is almost like an extension of yourself. If you forget your phone, it’s like a missing limb. But the communication bandwidth to the phone is very low, especially input.”

That’s why humans desperately need to catch up.

What do you think of robots and cyborgs? What do you think the impact of robots and cyborgs will be on society? What do you think of robots and cyborgs in the context of the pandemic?

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Robots on the rise as Americans experience record job losses amid pandemic

The pandemic has left millions of Americans unemployed – including many in the hospitality industry, which has seen a rise in the adoption of new tech
Lauren Aratani
Fri 27 Nov 2020 03.00 EST, Last modified on Fri 27 Nov 2020 06.06 EST
Source: The Guardian

Pepper, a robot developed by SoftBank Robotics, welcomes customers in Tokyo, Japan, on 5 November. In the US, 11 million people were unemployed in October.
 Pepper, a robot developed by SoftBank Robotics, welcomes customers in Tokyo, Japan, on 5 November. In the US, 11 million people were unemployed in October. Photograph: Kimimasa Mayama/EPA
Source: The Guardian
Shidonna Raven Garden and Cook

They can check you in and deliver orange juice to your hotel room, answer your questions about a missing package, whip up sushi and pack up thousands of subscription boxes. And, perhaps most importantly, they are completely immune to Covid-19. While people have had a hard time in the coronavirus pandemic, robots are having a moment.

The Covid-19 pandemic has left millions of Americans unemployed – disproportionately those in the service industries where women and people of color make up the largest share of the labor force. In October, 11 million people were unemployed in the US, compared with about 6 million people who were without a job during the same time last year.

The rise of the Covid robots – in pictures

And as humans are experiencing record job losses and economic uncertainty, robots have become a hot commodity. Multiple technology manufacturers have reported increased demand for their bots over the course of the pandemic, from drone-like machines that can roam hallways to make deliveries and AI-powered customer service software to increased use of self-service checkouts at supermarkets.

A recent report from the World Economic Forum predicted that by 2025 the next wave of automation – turbocharged by the pandemic – will disrupt 85m jobs globally. New jobs will be created but “businesses, governments and workers must plan to urgently work together to implement a new vision for the global workforce”.Advertisement

The hospitality industry, which has been one of the hardest-hit by the pandemic, has seen a clear uptick in the adoption of new technology during the pandemic. Hotels are allowing guests to use kiosks to check themselves in, apps to control the television and light switches in their room and a few use delivery bots to send to guests’ room when they want a refreshment.

Ron Swidler, chief information officer of the Gettys Group, a hotel design and development consultancy firm, said more hotels are experimenting with new technology during the pandemic. Swidler leads the Hotel of Tomorrow, a consortium of hospitality leaders that was re-upped in the middle of the pandemic to think of ways to innovate the industry. The group came up with five “big ideas” on how the industry needs to change, and new technology – including robots – are a core part of the equation.

“The cost [of automation] is coming down, the technology is getting better and we are seeing innovation working effectively in other parts of the world that we can transfer here,” Swidler said, citing Alibaba’s FlyZoo hotel that is staffed nearly entirely by technology, from check-in to room service.

While the idea of being serviced by a BB-8 lookalike in a hotel may seem strange, Swidler said permanent job losses in the industry will be a reality as hotels adopt new technologies to try to save on labor costs.

It is unclear whether the increased demand for new technology has directly caused job losses during the pandemic, but a discussion paper published by the Federal Reserve Bank of Philadelphia in September found that “automatable” jobs – occupations that could be replaced by technology that is in development or is already available – lost 4.2 more jobs per every 100 than occupations that are less at risk for automation. Occupations that are considered automatable include hotel desk clerks, shuttle drivers and retail salespeople, according to the paper.

The paper’s authors raise the widely shared concern that the automation undertaken during the pandemic will be a permanent replacement for jobs.

“The longer time it takes to fully control the virus, the higher the probability that the labor-saving technology will become permanent,” said Lei Ding, senior economic advisor at the Federal Reserve Bank of Philadelphia and co-author of the paper. “Job losses will become permanent losses.”

Currently, there are only anecdotal examples of permanent job loss due to an uptick in automation brought on by the pandemic, but the layoffs of hundreds of Pennsylvania toll booth workers provides one clear example of how labor-saving technology can sweep away jobs.

In June, the Pennsylvania Turnpike Commission laid off about 500 toll collectors in the state when it switched to all-electronic toll collecting.

For years, the commission had talked about replacing toll booth workers with automated collectors, and they finally gave workers a timeline. Per a union agreement, workers were supposed to be kept on payroll until at least October 2021, with final layoffs happening by January 2022.

The longer time it takes to fully control the virus, the higher the probability that the labor-saving technology will become permanentLei Ding

When the pandemic arrived, collectors were sent home in March and were promised that the commission would still uphold the October 2021 date. But in June, the commission permanently laid off all workers, over a year before the agreed date.

“We understand the safety of employees is the most important thing, but for them to have safety mean the elimination of their jobs … It’s been devastating,” said Jock Rowe, principal officer for Teamsters Local 77, the union representing 300 of the laid-off toll workers.

Rowe cited other toll-collecting agencies that brought back toll workers with enhanced safety measures, including the Port Authority of New York and New Jersey.

The impact of a recession on the growth of automation has been well-documented by economists and has shown that automation does not grow steadily, but rather happens in bursts. Businesses are more likely to automate after experiencing economic shocks, when they have strong incentives to save on labor.

For a study published in 2016, researchers from the University of Rochester combed through 87m job postings online from before and after the Great Recession. They found that employers in cities that were hit hardest by the recession were replacing workers with labor-saving technology and more skilled workers. A report published by the Century Foundation found that “robot intensity” increased in 2009, in the immediate wake of the Great Recession, particularly in the manufacturing industry.

While an increase in automation can be good for educated workers and help to stimulate the economy, studies have also shown that new technology tends to leave low-wage workers behind.

“Automation has been a major driver in the increase in inequality,” said Daron Acemoglu, an economist at the Massachusetts Institute of Technology. Acemoglu co-authored a study published in May that showed automation creates a “prosperity gap” that benefits high-skilled workers at the sake of lower-skilled workers.

Low-wage workers are not only more susceptible to job loss and wage depression due to automation, but they also experienced the most job losses due to shutdowns. Higher-wage workers are more likely to be able to work from home during the pandemic, while lower-wage workers – a disproportionate number of whom are Black or Hispanic – were more susceptible to layoffs due to shutdown orders.

Automation has been a major driver in the increase in inequality, Daron Acemoglu

An important caveat many roboticists will point out is that artificial intelligence technology is not quite smart enough to cause mass waves of layoffs due to robots. New AI technology can take a lot of money, time and resources to set up, something that many businesses do not have during the pandemic.

“You should definitely not worry about losing your job to an AI-enabled robot right now. If you’re going to lose your job to automation, it’s going to be … some proven, well-known automation that is more than 10 or 15 years old,” said Matt Beane, an assistant professor at the University of Santa Barbara’s Technology Management Program.

AI has “tremendous potential for making humans more productive” without replacing humans, Acemoglu said, if society takes a human-centric approach to technological advances. But without the political will to make sure those who do lose jobs are taken care of, by training them for new jobs, for example, the impact of automation may be devastating and a pandemic that has already hit those workers hardest could be leave a lasting legacy of unemployment.

“I’m not saying automation is terrible … What I’m saying is it would be terrible if we put all the eggs in the automation basket,” Acemoglu said. “We have to a large extent done so over the last 30 years. [The pandemic] will just exacerbate that.”

How do you think automation and robots have changed the economy? How do you think robots in the context of the pandemic have impacted job loss? Why?

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Department of Computer Science Research

Robots Shidonna Raven Garden and Cook

Advancing Robotics Technology for Societal Impact (ARTSI) Alliance

PI: Dr. Chutima Boonthum
Co-PI: Mr. Solomon Isekeje (Department of Fine and Performing Art)
Source: School of Science, Hampton University
Feature Photo Source: Unsplash, Possessed-Photography

The Department of Computer Science, School of Science, Hampton University received a $125,667 grant (2007-2010) from the National Science Foundation (NSF) to enhance the robotics programs for undergraduate students and to create outreach events for local K-12 students. The award is a part of a $2 million grant awarded to the Advancing Robotics Technology for Societal Impact (ARTSI) Alliance, a collaboration of institutions including eight Historically Black Colleges and Universities (HBCU) and seven Carnegie Research I Institutions.

How do you think robots impact our society? How do you think robots impact other societies? Why?

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White House Blocks New Coronavirus Vaccine Guidelines

1dimitri-houtteman-unsplash Shidonna Raven Garden and Cook

Source: The New York Times
The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

Sharon LaFraniere
Noah Weiland

By Sharon LaFraniere and Noah Weiland

WASHINGTON — Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response. White House officials have repeatedly intervened to shape decisions and public announcements in ways that paint the administration’s response to the pandemic in a positive light.

That pattern has dismayed a growing number of career officials and political appointees involved in the administration’s fight against a virus that has claimed more than 209,000 lives in the United States.

The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.

“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded on Thursday, in a letter to President Trump’s health secretary, Alex M. Azar II, asking for release of the guidelines.

The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.

A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.

The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.

That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment.

Speaking to reporters on Sept. 23, Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”

F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived. But they have been unable to break the stalemate.

The White House has the authority to intervene in such nonbinding guidance documents — a step below enforceable regulations — at least partly because of an October 2019 executive order that tightened restrictions over the issuance of such documents. That order asserted that “agencies have sometimes used this authority inappropriately in attempts to regulate the public.” White House officials have cited it to force the Food and Drug Administration and other agencies to submit pandemic-related guidelines to the White House budget office for review before public release.

Staff members at the budget office scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.

The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.

The Food and Drug Administration’s new guidelines were intended to assure companies developing vaccines that they were being held to a common standard and to reassure the public. Polls suggest that Americans are increasingly wary about taking a coronavirus vaccine: A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.

Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said last week in an event organized by Friends of Cancer Research that the government had to be transparent about the standards it was using to evaluate experimental vaccines in order to build public trust. He and other health officials have stressed that the companies developing vaccines are already fully aware of the agency’s expectations for products seeking authorization for emergency use.

Mr. Azar on Friday played down the conflict with the White House, telling a House panel that those concerned about its involvement in the guidelines were making “a mountain out of a molehill.”

“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Mr. Azar said. “The F.D.A. has already told the manufacturers what they’re going to look for.”

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.

At a recent meeting with F.D.A. staff members, Dr. Marks said the agency “may hear more noise in the press” about trouble with the guidance but added that the “goal isn’t to get into fights,” according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no reason “to get all excited” because “we are going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”

Privately, Dr. Marks has told colleagues that an angry tweet from Mr. Trump attacking F.D.A. scientists over the guidelines could damage public confidence in a coronavirus vaccine.

The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the committee’s next meeting, scheduled for Oct. 22.

Food and Drug Administration officials hope the committee will consider those standards before giving its blessing to any emergency use authorization for a vaccine. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers.

In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.

Katie Thomas contributed reporting from Chicago. Kitty Bennett contributed research.

How do you feel about a coronavirus vaccine? What do you think the guidelines will be? Will you take a coronavirus vaccine?

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Interfacing Humans and Technology – Elon Musk

We are already cyborgs | Elon Musk | Code Conference 2016

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Elon Musk – Cyborgs
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Elon Musk is the CEO of Space X and Tesla Motors. Space X has begun commercial space travel transportation and recently returned a group of Astronauts from space splashing them into the Gulf of Mexico. He is by far one of the people on the cutting edge of space and technology not to mention engineering and other talents. Musk also began many successful and well known companies such as PayPal. As one thinks about medical devices and the concept of cyborgs, one can see how the current science and medical trend of interfacing humans and technology. How do we see this in our everyday lives? How do we see this occurring in our doctors offices? How do we see this in our interactions with technology and technological advances? What if you became too slow to compete with robots or Ai (artificial technology) on a job? Would you interface with technology to become more competitive? What are the health implications of doing so? Share your comments with the community by positing your comments below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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Medications & Substance Abuse

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There is nothing more sensational than a star and their story of substance abuse. The questions is how do they get there. Indeed COVID 19 has highlighted the pharmaceutical industry as the world waits on the edge of its seat for a cure. In the mist of the pandemic many companies have gone under; others have faced tough times and decisions and yet others have re-invited themselves: namely Kodak. Kodak, famous for photo production, has now decided to get into the pharmaceutical business. Indeed there are many medicines, typically derived from nature, that have made a world of difference. There is no denying that the pharmaceutical industry makes several millions annually and often repackage a drug already on the market so they can circumvent clinical trails. The purpose of clinical trails is to confirm the medicine works and does what it claims to do.

Several times we have been offered medicines or a procedure that could be avoided by making changes in our diet, i.e. dialysis in place of increasing iron intake and taking a dietary supplement. In fact the medicines can add up quickly during one hospital visit. In some cases the symptoms produced by one medicine lead to the prescription of another medicine to address conditions one would not have if they did not take the medicine. In fact many doctors report that their patience soon suffer substance abuse. But many medicines are some type of drug. Its easy to see how multiple drug prescriptions can lead to substance abuse if one is not careful.

How many medicines do you take? What are they for? What are their sources in nature? Share your posts below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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