Showing posts with label science. Show all posts
Showing posts with label science. Show all posts

Friday, April 5, 2019

ARPA-E Should Not Ever Be Shutdown Period.





The Trump Administration has waged war to close the Advanced Research Projects Agency-Energy Program (of division) over the last two and a half years.  Why?  In large part because President Obama created ARPA-E which immediately sets the organization into the crosshairs of the Congressional budget committee each year.  The behavior of the President is strange given that both Republicans and Democrats feel that funding for ARPA-E as an organization is critical to meet the energy needs of the future of the United States.



To understand the motivation further of the Trump Administration, let's take a look at the Wikipedia page description of the Agency:



Legislative history 
The concept of ARPA-E was initially conceived by a report by the National Academies entitled Rising Above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future. The report recognized a U.S. need to stimulate innovation and develop clean, affordable, and reliable energy.[1] ARPA-E was officially created by the America COMPETES Act , authored by Congressman Bart Gordon,[2] within the United States Department of Energy (DOE) in 2007, though without a budget. The initial budget of about $400 million was a part of the economic stimulus bill of February 2009.[3] Then in early January 2011, the America COMPETES Reauthorization Act of 2010 made additional changes to ARPA-E’s structure; this structure is codified in Title 42, Chapter 149, Subchapter XVII, § 16538 of the United States Code.
Among its main provisions, Section 16538 provides that ARPA-E shall achieve its goals through energy technology projects by doing the following:
(1)Identifying and promoting revolutionary advances in fundamental and applied sciences;
(2)Translating scientific discoveries and cutting-edge inventions into technological innovations; and
(3)Accelerating transformational technological advances in areas that industry by itself is not likely to undertake because of technical and financial uncertainty. 
Mission 
Like DARPA does for military technology, ARPA-E is intended to fund high-risk, high-reward research that might not otherwise be pursued because there is a relatively high risk of failure.[4] Like DARPA, it is intended to fund projects involving government labs, private industry, and universities. ARPA-E has four objectives:
(1)To bring a freshness, excitement, and sense of mission to energy research that will attract the U.S.'s best and brightest minds;
(2)To focus on creative, transformation energy research that the industry cannot, or will not support due to its high risk, but that has high reward potential;
(3)To utilize an ARPA-like organization that is flat, nimble, and sparse, capable of sustaining for long periods of time those projects whose promise remains real, while phasing out programs that do not prove to be as promising as anticipated; and
(4)To create a new tool to bridge the gap between basic energy research and development/industrial innovation.[4] 
Launch 
President Barack Obama announced the launch of the Advanced Research Projects Agency–Energy (ARPA-E) on April 27, 2009 as part of an announcement about federal investment in research and development and science education. Soon after its launch, ARPA-E released its first Funding Opportunity Announcement for the new agency, offering $151 million in total with individual awards ranging from $500,000 to $9 million. Applicants submitted eight-page "concept papers" that outlined the technical concept; some were invited to submit full applications.[5]
Arun Majumdar, former deputy director of the Lawrence Berkeley National Laboratory, was appointed the first director of ARPA-E in September 2009, over six months after the organization was first funded.[6] U.S. Secretary of Energy Steven Chu presided over the inaugural "ARPA-E Energy Innovation Summit" on March 1–3, 2010 in Washington, D.C..[7]


After reading the above excerpt, who would not want to provide funds for the research initiatives conducted by ARPA-E.  With that being said, the only real reason which I can find for shutting down the program (aside from Obama's vision) is that the funding is for renewable/clean energy for the future of the United States.  ARPA-E is a spin-off from DARPA (Defense Advanced Research Projects Agency).



DARPA projects are specifically aimed at the military.  Years ago in graduate school, I had a research project which was funded by DARPA.  The research project was centered around the understanding of limits of quantum computation (quantum information processing) using Solid-State Nuclear Magnetic Resonance Spectroscopy (SSNMR).  Members of the public might think that there is no connection between the SSNMR spectroscopy and the military.



Although, the progress made on the project would indirectly improve the measurement known as Magnetic Resonance Imaging (MRI) in the hospital setting.  Funding for DARPA projects is usually aimed to fund projects which are high risk with large pay-offs along with high failure rates.  The range and scope of projects which are supported by DARPA are large.  Which is partly why a specific agency was created -- aimed explicitly at renewable energy research.



Additionally, the need to fund renewable energy projects which pose a large pay-off with a high risk of failure is essential.  As I emphasized earlier, the need to have a broad portfolio of diverse research projects is critical.  Casting as wide of a net as possible ensures a diverse range of technologies which result from the initial plans.  Therefore, keeping the funding source open and increasing the level of funding annually, ensures a healthy nation which keeps up with the pace of developing (and researching) new technologies.



In light of the obvious, universities and private organizations have banded together to show support for the continuation of ARPA-E funding into the future.  Here is the letter of support from many organizations (corporations and universities) for the extension in arpa-e financing (and program):


Dear Chairman Alexander, Ranking Member Feinstein, Chairwoman Kaptur and Ranking Member Simpson,
As diverse organizations interested in the Department of Energy’s Advanced Research Projects Agency – Energy (ARPA-E) program, we thank you for the significant funding for this vital program in Fiscal Years 2018 and 2019. ARPA-E plays a unique and critical role in maintaining America’s global leadership in energy technologies. As you begin drafting the Fiscal Year 2020 Energy and Water Appropriations bills, the undersigned organizations, companies and institutions urge you to enhance our competitiveness and energy security by supporting robust funding for ARPA-E in the Fiscal Year 2020 appropriations bill.  We support funding ARPA-E at least at $400 million in Fiscal Year 2020. This is roughly $35 million higher than in Fiscal Year 2019 and would allow for one additional program solicitation to pioneer advances in a high-impact energy technology area.
ARPA-E is a highly innovative and effective program which enjoys strong bipartisan congressional support. Since its inception, ARPA-E has successfully sponsored a dynamic range of research, including technologies with potentially profound benefits for the nation’s future energy security. Modeled after the highly successful Defense Advanced Research Projects Agency (DARPA), ARPA-E supports “high-risk, high-reward” research which has the potential to drastically alter how we make and use energy in the future. The program utilizes a unique organizational structure and highly successful selection process to identify innovative technologies, pushes them to meet aggressive milestones and helps them to cross the valley of death so the private sector can then commercialize them.
Despite being just ten years old, ARPA-E is already fostering technological breakthroughs in energy storage, transportation fuels, and industrial efficiency. To date, 136 of more than 340 completed projects supported by ARPA-E have attracted over $2.6 billion in private sector follow-on funding, and 71 projects have gone on to form new companies. The enthusiasm for ARPA-E’s vision and quality of work is evidenced by its ability to repeatedly draw more than 2,000 entrepreneurs, state and federal government officials, state and federal agencies and large numbers of investors to its annual Energy Innovation Summit.
The importance of U.S. leadership in energy technologies to our economic and energy security makes ARPA-E a tremendous competitive advantage for our nation. Stable and sustained funding growth is necessary to ensure this successful program continues to enhance America’s ability to pioneer the energy technologies of tomorrow. 






and the signers were from the following organizations:



American Chemical Society
American Council for Capital Formation (ACCF)
American Geophysical Union
American Society of Agronomy
Association of American Universities
Association of Public and Land-grant
Universities
BASF Corporation
Bettergy Corp.
BPC Action
Brayton Energy
Citizens for Responsible Energy Solutions
Clean Energy Business Network
Clean Energy Trust
Cleantech Alliance
ClearPath Action
Copper Development Association
Crop Science Society of America
Dioxide Materials
Duke University
E2 (Environmental Entrepreneurs)
Elemental Excelerator, Inc.
Energy Technology Savings, Inc.
Environmental Defense Fund
Fearless Fund
Flash Steelworks, Inc
Florida State University
General Electric
Georgia Institute of Technology
Gnosys, Inc.
Greentown Labs
Industrial Microbes, Inc.
Information Technology and Innovation
Foundation
Intel Corporation
Introspective Systems
Ionic Materials, Inc.
LEEDCo
Malta Inc
Marine BioEnergy, Inc.
Massachusetts Institute of Technology
Michigan State University
Michigan Technological University
National Audubon Society
National Venture Capital Association
National Wildlife Federation
Natron Energy, Inc.
Natural Resources Defense Council
Newton Energy Group LLC
Nuclear Energy Institute
Onboard Dynamics, Inc.
Otherlab
Pajarito Powder, LLC.
Penn State University
Powerhouse
Princeton University
Prospect Silicon Valley
RedWave Energy, Inc.
SAFCell
SixPoint Materials, Inc.
Soil Science Society of America
Solar Energy Industries Association
Spruce Capital Partners
SSTI
Starfire Energy
Stony Brook University
Swift Coat, Inc.
TechNet
Tenley Consulting
The Nature Conservancy
The State University of New York System
The Texas A&M University System
Third Way
United Technologies Corporation
University of California System
University of California, Berkeley
University of California, Los Angeles
University of California, Merced
University of California, San Diego
University of Colorado Boulder
University of Houston System
University of Illinois at Urbana-Champaign
University of Illinois System
University of Maryland, College Park
University of North Carolina System
University of Oregon
University of Rochester
Urban Future Lab/ ACRE Incubator
US Chamber of Commerce
Vanderbilt University


The above signatures (organizations) represent a massive research consortium.  From industry to academia, there is full support for ARPA-E.  Especially, since investment in energy projects will undoubtedly return dollars to the market in one form or another (either directly or indirectly).  Congressional leaders realize the importance of funding a diverse portfolio of projects both aimed at improving the military side of the nation along with projects aimed at society in general.  More often than not, investment in either pays off in some manner.



Investing money into research might seem pointless at times.  Although, if we look back into history and see the numerous advances which have come out of research spending, funding projects into the future would not ever be questioned.  That is not to say we (as a nation) should throw money at any given research project being proposed.



To close the loop on this conversation, check out this short video about ARPA-E which introduces a few of the concepts which drive research at the organization:





A nation with a diverse and appropriate funding scheme which supports a wide range of projects stands to gain the most.  The United States spends most of GDP on research compared to other nations.  Although, the United States also benefits the most from their investments.  The correlation is obvious.  Spend more and get more.  But spend smart too.



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Monday, April 1, 2019

IVF from a husband’s point of view (Part 1): Should we do it?


                        Image by Elena Έλενα Kontogianni Κοντογιάννη from Pixabay




The flow of the conversation usually would start with: “Mike, you know the beginning for a man is easy…just give a semen sample.  Your part is easy compared to the beginning for a female.”  To which I would pose zero opposition toward doing.  The entire conversation was not long,  with an ending along the lines of “I have no problem with starting, I am just waiting for Kayla to want to start IVF.  When she is ready, I am too.”



That was partly true, except for two intervening hopes on Kayla and my part: (1) After Kayla was ready (mentally and physically) along with (2) the place where we were financially stable – we both hoped that we would naturally get pregnant.  The reality was, any day now, we just needed to bite the bullet and start the In Vitro Fertilization (IVF) process.   Let’s back up a bit and give a little context up to this point for clarity.



Wait Until You Start Your Career



Kayla (my partner) and I met in graduate school at the University of California at Riverside.  Both of us were in the doctorate program in chemistry.  I was 34 years old at the time while Kayla was 27 years old.  I had been in the doctorate program for 4 years already when Kayla joined the department to become an analytical chemist.



Life was easy at the time for two graduate students without children living a life of studying and working in a laboratory while hitting the clubs at night.  Not a healthy life, but a busy life and living at full throttle.  The thought of undergoing an IVF treatment was the furthest outside of my mental orbit.



Any person who has enrolled in a graduate program to obtain a degree understands that a substantial amount of time is required on a student's part to earn a degree (i.e., a Ph.D.).  That being said, there are many ways to live a life worth living as a graduate student.  Just like there are many ways to live a good life.   Getting a higher education degree is one way to do so.  Although, obtaining a degree is not required to live a good life.



While Kayla and I were in graduate school, the advice from both her advisors along with mine landed squarely on the following line: Wait Until You Start Your Career To Have Children.  Many students take that advice to heart.  Including women such as Kayla who are under the added pressure women feel as opposed to men.  I will say very bluntly -- academic (research) advisors do not necessarily have your best interest in mind.  Yes.  I did just say be careful how you process the advice that your advisor disseminates to you regarding the path leading to your career.



Spoiler Alert: Now would be a great time to have a discussion with your partner about starting the IVF treatment process.  At least considering pursuing the process of harvesting eggs and retrieving them to freeze for later.  In part 2, the reason will be revealed.  The drawback is the cost, although, loans are possible to get -- specialty loans for the IVF treatment exclusively.  Back to the story.



Our take away at the time was that research advisors are treated on the same level as "God" -- which would result in using contraception instead of having children while in graduate school.  That is not to say having children will be easy or allow a person to graduate on time.  Again, there are a variety of ways to get through graduate school successfully.



I will say at the time, Kayla and I were living a life which was intertwined with alcohol addiction which is not necessarily the perfect atmosphere to have children. Basically, during the years of graduate school, the thought of having children was a big NO.  For us, the decision to have children was not on the table during graduate school.




Photo by Charles DeLoye on Unsplash



Career Starts Now!




I was ahead in my graduate time-line than Kayla which would make my graduation happen two years sooner.   As a result, I found a temporary position as a Post Doctoral Fellow conducting research down at the University of California at San Diego.  Living in La Jolla is excellent.  Although, under the stress of having dual households along with a Post Doctoral research position is not.  I was stressed out along with Kayla.  Money was tight.  We were still trying to party like rockstars -- which was now at full throttle.  Life was fast - career was beginning.  No time for babies yet.



At the same time, my colleagues (fellow PostDocs as they are called) were having children.  But with a dual household (one in La Jolla and one in Riverside), there was zero chance at having a child.  Another excuse right?  Yep.   This lasted a year and a half until Kayla was near graduating and found a job for me at the California State University at Northridge.  I currently work here along with Kayla.



I managed (with the help of my wonderful wife) to start a career as a full-time position as an instrument manager at a university in the North Los Angeles area (California State University at Northridge).  Whereas Kayla initially bounced around trying to build up a teaching career by teaching part-time at various colleges.  Again, she was holding out on having children until she found a 'full time' position.  When were we going to have children?



Just around 6 years ago, Kayla and I decided to give up alcohol and other vices.  Which was great if we were planning on having children right?  The process has been more straightforward with the assistance of Alcoholics Anonymous (AA).  Which is not for everyone.  AA has helped us tremendously in keeping sobriety and preparing our lives for having children.  Sounds crazy right?  In actuality, the process has been an educational journey which has opened our eyes toward progress which extends beyond child rearing.  Success in life in general -- maintaining peace from within.



Right about now, you may be thinking ... "Who are these crazy AA people?"  That is the furthest from the case. The program (and its success) of Alcoholics Anonymous speaks for itself.  That is all that will be said on the matter moving forward.  This change was part of a more significant difference -- one toward having children.



Throughout the process of getting sober, Kayla and I made changes to make our lives much more straightforward.  One realization of Kayla's part was that driving around Southern California to many community colleges teaching part-time was not the desirable lifestyle she had wished for herself.  She came to the realization that both of us working at the same institution (university) would be much simpler.  And it was indeed.



Therefore, she started teaching part-time at CSUN in the same department as me.  This allowed us to move closer to our work (across the street) and have a more sustainable lifestyle.   At the same time, she seemed to be settling down into a career mindset.  Over the last few years, she has definitely arrived at a more relaxed state of mind and become much more secure with herself.  All indications that the next move would be to try to start a family.



We definitely thought that having unprotected sex for a couple of years would do the trick.  Nothing happened.  Recently, Kayla downloaded the app called "Clue" to help her realize when the most 'Fertile' day would be -- still nothing.  We went to the doctor to get a referral to see a fertility physician.  Throughout the process, we were told to lose weight and try naturally.



There is a point at which this advice does not work anymore.  To all of the men out there pay attention to the history of your relationship and take note.  Eventually, you may be the person deciding to start the IVF treatment.  Having to step up and spearhead the operation is not fun, but finally needed to be done.



Late last year, we never went to see the fertility specialist.  On top of that, Kayla suddenly said to me out of the blue ... "Mike, we need to get pregnant now to align the delivery with summer?"  This turned into a massive conversation which ended with a decision -- to have IVF - In Vitro Fertilization.  What was the timeline going to look like?  How long would the process take to see the right physician?  What was the next step?  Oh My Goodness.  What do I do?  How did I (as the husband) miss the prominent notice -- time to have children - NOW.



Go To A Baby Shower For Advice?



As a husband, the goal is to respect and help my wife have as great of a life as possible.  Of course, we both need to be happy.  Both are possible.  I am 46 years old and thinking about when a potential baby would be born and turning 20 years old.  That would make me 66 years old.
Meanwhile, my friends have grandchildren.  Oh My Goodness.  I made choices - none of which I regret.  Now, where do we go from here?  How to get started?



Luckily, an old friend from graduate school reached out on Facebook and informed Kayla about an upcoming baby shower.  This particular friend had married my former roommate.  Perfect.  Let's catch up on old times.  She recently went through IVF (over the past year and a half).  Wow.  This interaction at the party was a godsend.  My old roommate informed me of the difficulty and challenges which were stated as minimal.  Both mentioned the most challenging aspect were the many doctor visits.  Yes, there are many.  As I will tell about in part 2 of the series.



The result of attending the baby shower was a definite decision to go to the same reproductive center as they had used.  Why wouldn't we try the same place?  This party happened last July.  We just started the process in January.  I had to put my foot down and say: "The time has come to try IVF"  That is if we were going to try at all.  To all of the husbands out there, do not be afraid of starting to initiating the conversation.  Many men would like to stay as far away as possible from the discussion.



Unfortunately, the longer that you wait to begin, the more risk that you have toward not having (harvesting) enough eggs to make embryos which turn into children.  I will talk about that in part 2.  I hope that men will read this and be strong enough to have a conversation about children, further, about the process of IVF.  There is a financial aspect, but the central part is the decision to commit to the process.  The two of you are experimenting with your partner’s body to produce a beautiful child.



Therefore, if the conversation has not begun, have it.  The reality is that (as you will see), there are more people in a similar dilemma like yourself.  And that you may regret not dealing with this sooner.  Above all else, men are not alone.  Other men are going through the same experience and having similar or worse thoughts.  Women, I cannot speak for you.  Nor do I wish to.  I will say this about the process; thus far...this has been the right decision to just jump into it and not wait.  Part two will cover the first part of IVF from a husband's perspective -- up to the embryo testing.



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Saturday, March 30, 2019

President Trump Tries To Open Up Arctic For Oil Drilling, Judge Says No





Breaking news -- not really.  Read all about it...President Trump tries to open up the Arctic Ocean for oil drilling and is met in court with a response of 'No':



 In a major legal blow to President Trump’s push to expand offshore oil and gas development, a federal judge ruled that an executive order by Mr. Trump that lifted an Obama-era ban on oil and gas drilling in the Arctic Ocean was unlawful.
The decision, by Judge Sharon L. Gleason of the United States District Court for the District of Alaska, concluded late Friday that President Barack Obama’s 2015 and 2016 withdrawal of about 1120 million acres of Arctic Ocean from drilling “will remain in full force and effect unless and until revoked by Congress.” She wrote that an April 2017 executive order by Mr. Trump revoking the drilling ban “is unlawful, as it exceeded the president’s authority.”
The decision, which is expected to be appealed in the Ninth Circuit Court of Appeals, immediately reinstates the drilling ban on most of the Arctic Ocean off the coast of Alaska, a pristine region home to endangered species including polar bears and bowhead whales where oil companies have long sought to drill. It also has broader implications for Mr. Trump’s effort to push drilling across the American coastline and on public lands.
Specifically, the Arctic Ocean drilling case could give legal ammunition to opponents of Mr. Trump’s efforts to roll back protections for two million acres of national monuments created by Mr. Obama and President Bill Clinton.



With each passing day, the news is filled with updates on the success of the transition toward a renewable energy future.  Some may detail certain obstacles while others break the news regarding either a private entity or government moving (or making a commitment) toward achieving a non-zero percentage of their energy economy on clean (renewable) energy.  This reality is not new.



Neither is President Trump's inability to realize that 'rolling back' environmental laws put in place by the Obama Administration takes skill (and reason/logic) to reverse.  Congress will have to act at the very least.  Within that act will have to be a good reason to repeal the law put into place.  I have previously stated on this blog site the fact that if a rule is to be changed, the replacement has to be better than the previous law.



Which is to say that the law needs to be even more environmentally friendly than the previous proposal to be passed.  Otherwise, the existing law stays in place and is continuously challenged in courts -- as has been the case for the Trump Administration over the last two years.   I try hard to explain that rule to everyone with whom I meet and discuss the 'rollbacks' that supposedly have been accomplished by the Trump Administration.



The reality is stated in the article above that the Trump Administration has failed miserably on at least 40 accounts to persuade courts to reverse or 'rollback' a given environmental rule put in place by the Trump Administration.  These decisions have been in line with the current standards set in place by Congress.  Which should surprise no one including the President of the United States.  We will next have to see what Congress says about the issue at hand.



So far Congress has been willing to hold bipartisan hearings this year on the critical issue of climate change.  Furthermore, Congress recently wrote a letter to the Director of the Department of the Interior, asking him to not drill for oil off the coast of Florida.  That should be a significant indicator to President Trump that his attempts to 'rollback' any Obama Administration's environmental regulations (at least the majority of them) is not an accessible route to go down.



Of course, we are dealing with a non-traditional President of the United States currently.  The newspapers should keep up the great work at reporting on such failures.  Otherwise, a person might be led to think that a 'rollback' is possible without Congress.  The reality is that even Congress is batting for a renewable energy future.  Although the timeline might be debatable.  Nonetheless, a clean, renewable energy future is coming.  Stay tuned.



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Tuesday, March 26, 2019

Can A Plant Pathogen Be Transported By Wind During A Rain Storm?


Source: WuzupNigeria



The spread of seeds, particles and pathogens over considerable distances is of great concern.  Especially given the current trend of converting crops from tradition crops to GMO (genetically modified crops).  Proprietary seeds are held tightly among farmers who pay to plant special seeds.  The ability to protect the spreading of seeds under storm conditions is nearly impossible.  That is during normal conditions -- i.e. normal weather: sunny, average temperature, humidity level for a given geographical area -- seeds are controlled by the human distribution of seeds.  What happens to this phenomena (spreading of spores, seeds, particles, dust, pathogens, etc.) during a rain storm?


Rain falls to the ground and forms puddles over time.  Water which gathers on the ground contains dirt, particles, pathogens, seeds, etc.  When a rain drops out of the sky and hits the ground during a wind storm, what happens to those pathogens (and other particles) in the water?  What about the surface of a leaf?  Do these pathogens (and particles) travel over distances during a rain/wind storm?  What is the mechanism by which pathogens (and particles) travel over large distances?



How do particles (and pathogens) get into the air?




Past research has shown that rust (build up on metal or other surfaces) can spread in a wind storm a considerable distance -- on the order of kilometers (1 mile = 1.60934 kilometers).  Research published last November in the Journal 'Proceedings of the National Academy of Sciences' revealed the mechanisms by which pathogens (and other particles) travel over large distances.  The study revealed the exact mechanisms broken down into parameters such as overcoming cohesive force between spores clustered together on a surface, the ejection mechanism (how to get off the ground into the air), and the traveling of the pathogen over large distances.   Next, add into the mix a rain storm with wind.



To break this down further.  Imagine a pathogen (or seed, particle, etc.) sitting on the ground.  The wind is rushing by above the surface on which the pathogen sits.  How does the pathogen acquire enough energy (kinetic energy) to be ejected into the air rushing by above?  That is where the researchers use high-speed cameras (as shown in the videos below) to tease out the exact mechanisms.  High-speed cameras show that a falling rain drop contains enough energy to eject a pathogen (and other particles) into the laminar air flow which can potentially travel over large distances.



Upon impact with the ground, the energy of the rain drop is distributed unevenly into a series of droplets which splash up and outward.  The kinetic energy of the outward water distributed creates enough of a vortex (as shown in the video below) to eject a pathogen from the ground up into the rushing air above the surface.  From there, the pathogen has sufficient energy to travel large distances given that the wind maintain a constant energy to push the pathogen along.



Also contained in the research paper are the simulations which were used along with the calculations (and equations) on which the phenomena was modeled.  The data was in agreement with the evidence obtained in the high-speed camera videos.  Here are two videos to show how the spores (plant pathogens) are elevated into the air once the drop hits the surface:







The second video shows the formation of a vortex by the rain drop which is one of a few critical parameters for pathogens ejecting off of a surface and joining a laminar flow to travel large distances:






The videos show above that there is sufficient energy in a rainwater drop to eject a pathogen (or other particles) up into the air.  Ejecting the pathogen is sufficient enough to catch a larger airflow of laminar air which could potentially carry the pathogen over large distances -- i.e. kilometers, miles, etc.   The research represents a good model by which pathogens can travel over large distances.  Previous research did not provide exact detail of vortex formation which would be sufficient to lift a pathogen into larger vortexes.


The research represents a quantification of dynamics of pathogen (disease) spreading among the plant community.  Rain drops are one pathway by which pathogens could acquire enough energy to be ejected into the air to travel large distances.  More studies will help optimize the conditions under which pathogens travel and possibly shed light into new avenues of mechanisms of ejection.  The ejection mechanisms uncovered in the research above add to the existing contribution from insects residing on leaf surfaces, leaf vibration, along with other kinetic energy contributions. Overall, the research represents yet another parameter revealed in disease propagation in the agricultural community.



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Wednesday, March 20, 2019

CERA Interviews What Appears To Be A New DOE Secretary Rick Perry - Wow!


Source: Fstoppers



Over the last few years, Department of Energy Secretary Rick Perry has been on an educational journey into the variety of ways which the United States will meet the energy demands of the future.  At the start of his tenure as Secretary of Energy, the major opinion of his knowledge was less than stellar  -- especially on the contribution which renewable/clean energy will play on the world table in the future.  With that being said, Secretary Rick Perry has since started to shy away from our dependence on coal (fossil fuel) based dependence and shifted toward Liquified Natural Gas (LNG).  I must commend him on changing his view over time through educating himself.



Recently, the annual conference on energy was held in the heartland of energy -- Texas -- named CERA (Cambridge Energy Research Associates) with the following mission:


In 1983, Cambridge Energy Research Associates (CERA) was founded in Cambridge, Massachusetts by Daniel Yergin and James Rosenfield. The energy research and consulting firm quickly became known for its critical knowledge and independent analysis on energy markets, geopolitics, industry trends, technology and strategy. Each year, CERA clients gathered for a few days in Houston, Texas to attend the executive conference where they gained insight into the energy future while connecting with their peers. Over time, the program was expanded to five days of informative sessions and networking opportunities—and named CERAWeek. More than three decades later, CERAWeek by IHS Markit has become the world’s premier energy event. The conference is distinctive in the extraordinary depth and breadth of its content and the quality of the dialogue among participants. 


The top minds of energy development along with the customers to the policy makers gather to discuss the future of energy.  A wide range of topics are covered including some which might at first sight seem unrelated to the global discussion of energy.  Some of these will be discussed in the video below and are worth considering as part of the larger picture of energy demand as the United States along with other nations move into the future of energy.  Let's listen to what Secretary Perry has in mind for the future in a brief interview below.



The video below is taken from the conference series CERA which is an interview between Carlos and DOE Secretary Rick Perry (which is 10 minutes in length):


Note: Click lower right hand side of the video screen to 'fullscreen' the video.




The future is exciting to say the least.  Energy transition encompasses more than meets the eye when the average American considers the wide range of technologies which energy support (namely nearly all).  Without energy, the world does not operate.  We do not operate on a daily basis.  How energy transition takes into account the changing global conditions such as climate change are the present topics to discuss and incorporate solutions into tomorrow's policy making decisions.  Secretary Perry shows the growth needed as a high ranking government official to entertain the parameters needed to make the energy transition a reality.  We should commend him on his growth through education.



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Tuesday, March 12, 2019

Update: On FDA's Policy Agenda For Combatting Opioid Crisis


Source: Politico



Last week, news broke that the current Commissioner of the Food and Drug Administration -- Commissioner Dr. Scott Gottlieb was leaving surprised everyone around Washington D.C.   Commissioner Scott Gottlieb has done wonderful work on very difficult problems facing our society, including Food Safety, Cosmetics Safety, expanding access to medication, and the largest plague of all -- Opioid epidemic facing the United States of America right now.  Under his command, the FDA has started to come up with an action plan on the opioid crisis -- which can be found here.  The web page on the FDA website for opioids is more informative and easier to navigate -- check it out here.



He also has given his perspective on the growing opioid problem through official outlets (Twitter, Facebook, etc.) along with official statements on the problem like that below.  The statement below represents the most recent -- Feb. 26th and his last before he leaves office.  Although, the statement gives the public a good future guide into the routes of a solution which the FDA will pursue into the next few years.



With that in mind, here is the update taken from the FDA website directly shown below:



The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced. It remains the biggest public health crisis facing the FDA. The toll of addiction, in lost lives and broken families, touches every community in America. Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.
At the FDA, we’ve worked to learn from past mistakes, and we intend to make sure that we’re acting forcefully enough to address new threats that could extend this crisis. Addressing the opioid crisis is a top priority of the Secretary of Health and Human Services and the entire Administration. The FDA is a key part of that effort.
We’re a deliberative, science-based agency. We calibrate our policy and regulatory actions carefully, based on rigorous evidence that can often take many months and even years to collect. This defines our gold standard for regulatory decisions. But given the scope of this crisis, and its human toll, we’ve committed to act more quickly as we confront new risks. We’ve changed our approach and are taking a much more aggressive approach to regulatory action. At the FDA, we’ve committed to taking more rapid action in the face of new threats, like the growing prevalence of illicit fentanyl that’s contributing to overdose deaths, or the continued prevalence of prescriptions being written for durations of use that are too long for the clinical circumstances for which they’re intended. We’ve changed the way we’re tackling these issues and stepped up our intervention when it comes to opioids. In this epidemic, waiting for the accumulation of definitive evidence of harm left us a step behind a crisis that was evolving quickly, and sometimes furtively, in vulnerable communities that were too often being tragically ignored.
To address this crisis differently, and more definitively, we’ve taken decisive steps in recent years, and have additional actions already underway for 2019, with more steps planned to begin this year.
We’re committed to getting ahead of this crisis. We don’t want to look back five years from now, at an even larger crisis, with regret that there were more aggressive steps that we could have taken sooner. All options are on the table. Addressing this crisis is one of the FDA’s top public health priorities. With this statement, I want to assess some of the steps we’ve taken and outline the new actions we’ll be pursuing.
FDA Actions in 2018
Prescribers have a critical role to play, and we must make sure they have essential information about opioids through drug labeling. In the fall, we expanded the extended-release and long-acting (ER/LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS) requirements to the immediate-release (IR) opioid analgesics intended for use in an outpatient setting. We’ve also updated the boxed warnings in the labeling for these products to include information about the REMS.
The REMS program was also expanded to require, for the first time, that training be made available to all health care providers, including nurses and pharmacists, who are involved in the management of patients with pain (in addition to doctors who prescribe these products). The content of the education was also broadened to cover information about acute and chronic pain management, safe use of opioids or other non-opioid or non-drug treatments, and material on addiction medicine and opioid use disorders.
The FDA also developed new solutions to address the unique risks of opioids in conjunction with our request for the market withdrawal of Opana ER in 2017. We will, as needed, continue to take strong regulatory steps to seek to limit or curtail access to certain drugs, based on formally assessing the risks associated with illicit use, as we did in the case of Opana ER with the risk of intravenous abuse. As part of our effort to consider the risks associated with the illicit use of opioids as one component of how we assess the overall risk and benefit of these medicines, we also worked with Congress to secure explicit authority to take action, as needed, on the basis of a consideration of these risks. This authority was included in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. In 2018 we also opened a dialogue around the potential for evaluating the comparative benefits and risks of new opioids relative to other opioids already on the market. Going forward we’ve raised the question of whether there should be such a standard for new opioid approvals to offer some advantage over the existing armamentarium. We raised this question in the context of the approval of the sufentanil product Dsuvia. We plan continue to evaluate this concept in questions that we’ll ask as part of a public docket alongside a draft guidance document that we’ll be issuing to modernize the FDA’s framework for assessing the risks and benefits of opioid drugs.
To reduce the rate of new addiction we need to reduce exposure to opioids. This means rationalizing prescribing, which in turn means that not only must we take steps to make sure fewer prescriptions for opioids are written, but also that when these drugs are prescribed, it’s for a dose and duration of use that comports closely with the clinical circumstance and the medical need of the patient. This means no more 30 tablet prescriptions for a tooth extraction. To pursue these public health goals, we’re working with stakeholders like the National Academies of Science, Engineering, and Medicine to create a scientific framework for developing evidence-based prescribing guidelines that provide specific recommendations on the proper dosing and dispensing of opioids based on specific clinical indications (like outpatient surgeries).
This will help support evidence-based guidelines in areas where they do not currently exist. This report will be ready at the end of 2019. We’re also conducting a review of data from product applications, in collaboration with an academic partner, to identify where adequate evidence exists to inform new guidelines. We believe there are clinical circumstances where there’s already adequate evidence to create evidence-based prescribing recommendations, and we’ll pursue the development of these guidelines.
In 2018, the FDA also continued work with other federal and state partners on numerous other changes started over the past several years to achieve more appropriate prescribing. Rationalizing prescribing practices by providers remains a cornerstone of our effort to reduce the rate of new addiction. And reducing the rate of new addiction is a key element of our overall approach to address this crisis. These combined actions across many federal, state, and professional entities are having an impact. Since 2015, the estimated number of opioid analgesic prescriptions dispensed from U.S. outpatient retail pharmacies (which may be the most vulnerable to abuse or diversion of prescription products) have fallen by 24 percent. Notably, prescriptions of higher strength opioids (90+ morphine milligram equivalents/unit) have fallen even more steeply since 2015, accounting for less than 1 percent of all opioid analgesic units (e.g., tablets) dispensed in 2018.
Although the appropriate use of opioids from prescription claims data cannot be determined, the risk of overdose has been shown to be intertwined with increasing dose and duration of opioid analgesic use. Overall, the estimated total number of opioid analgesic prescriptions peaked in 2012, to 260 million prescriptions from 145 million in 1997. The estimated total morphine milligram equivalents (MMEs) per prescription peaked in 2010, at 950 MMEs, before falling to 905 MMEs in 2015. However, the rate of overdose death continues to increase. This is due in part to the increasing abuse of potent adulterated or illicitly manufactured fentanyl products purchased through online channels and sold as street drugs.
As the opioid crisis has evolved, so has the nature of the threat. Opioids are still too commonly prescribed and lawful prescriptions still contribute to the development of new cases of addiction. But illicit opioids are accounting for a sharply increasing fraction of the total exposure to these drugs, and fueling a growing addiction crisis. Within the scope of our work, we’re especially focused on illicit online purchases. The flow of drugs on the surface and dark web has become a significant part of the epidemic relative to prescription opioids. To address the evolving nature of this threat, since 2017, we’ve warned a total of 23 networks operating more than 450 websites for illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol and oxycodone. Cutting off this illicit internet traffic is critical. We’ll continue to pursue all available means of enforcement to stop these online drug dealers.
In 2018 we also took actions to increase our interdiction work in the International Mail Facilities (IMFs). Specifically, as the nature of this epidemic has evolved to encompass greater flows and use of illicit opioid drugs, we’ve expanded our enforcement efforts to include increased interdiction work aimed at stopping the illegal flow of counterfeit and unapproved prescription drugs, which in numerous cases includes opioids.
The FDA expanded the capacity of import operations, made significant investments in our Office of Criminal Investigations, and our laboratories, including our Forensic Chemistry Center. These are important investments to help us identify and stop illegal drugs seeking to enter the U.S. including through the IMFs.
Over the last two months, the Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) have made significant progress to stop the activities of sophisticated bad actors who attempt to evade FDA enforcement at the border.
Among these new steps, we’re pleased to report that we’re implementing one of the new authorities in Section 3022 of the SUPPORT Act related to restricting entrance of illicit articles containing active pharmaceutical ingredients (APIs). This new authority (new section 801(u) of the Federal Food, Drug and Cosmetic Act) allows the FDA to treat illegal imported articles as drugs when they meet certain requirements—and stop them as needed—even in the absence of certain evidence of intended use. ORA has updated its IMF procedures to support implementation of this new authority to help prevent illegal drugs from entering our country. We’re also working on new tools to identify analogues of APIs that present s significant public health concern, to make sure that this important new enforcement tool against illicit drugs has its intended effect. The FDA will begin applying the new 801(u) authority to any imported product entering the U.S. via international mail which is labeled to be or contains, or is found through laboratory analysis to be or contains, any of the ingredients identified as presenting a significant public health concern. These new steps will make our operations in the IMFs more efficient and allow us to improve our interdiction work.
By supporting appropriate opioid prescribing, education, and labeling we’re reducing excess quantities of opioid analgesics available for abuse or diversion and helping to reduce the rate of new addictions from prescribed opioids. By strengthening our enforcement and inspections of packages purchased online and entering the U.S. from abroad, we’re helping to staunch the trafficking of even more powerful and deadly drugs (like illegal Chinese fentanyl) and address the changing nature of this crisis. By increasing the accessibility of medication-assisted treatment (MAT), and reducing stigma associated with it, we’re helping those struggling with addiction to return to lives of sobriety in their communities with dignity.
These are just some of the domains that we’re working across as we address this crisis using all of our tools and authorities. We know we must treat opioids very differently than other drug classes, and Congress has supported us in that effort by granting us very specific new authorities related to opioids.
FDA Actions in 2019
These are just some of the steps that we took in 2018 to address this crisis. In 2019, we plan on taking new actions to build on these efforts, and also adapt our response to confront the changing nature of the threat. We’ll continue to aggressively and compassionately pursue new efforts to address this tragedy.
Reducing Misuse and Abuse of Opioid Drugs
The FDA continues to have a critical and unique role to play in preventing cases of new opioid addiction – helping to reduce avoidable exposure to opioid analgesics and thereby reduce the rate of new addiction.
We’re taking new steps to reduce exposure to opioid analgesics by helping to ensure that these drugs are appropriately prescribed, with dose, quantity and treatment durations that match the indication. Passage of the SUPPORT Act has provided the FDA with important new authorities to assist in our effort to reduce the risk of addiction and misuse associated with opioid analgesics. For example, the new law allows the FDA to require certain packaging be made available for opioids and other drugs that pose a serious risk of abuse or overdose if the FDA determines that such packaging may mitigate such risks. We plan to implement the initial steps to require unit of dose packaging in the first half of 2019. Specifically, the FDA is considering use of this new authority to mandate that certain solid, oral dosage forms of immediate-release formulations of opioid analgesics indicated for treatment of acute pain be made available in short-duration packaging for outpatient dispensing. Such packaging could reduce over-prescribing by giving providers a convenient option that contains only enough drug doses for up to a few days of opioid treatment at standard dosing. Our data suggests that for many acute pain indications where opioids are used, a day or two of dispensed drug is the appropriate quantity. Small quantities in blister packaging, that comport with evidence demonstrating that a day or two of medication is sufficient, could reduce the overall amount of dispensed drugs available for misuse, abuse, and diversion.
The SUPPORT Act also allows the FDA to require manufacturers to develop disposal technologies (such as a mail-back pouches) to get unused medications out of medicine cabinets. This is another new authority that we’re prioritizing for work in the first half of 2019.
We’re also taking new steps to consider a framework to allow us to formally evaluate each candidate opioid in the context of how a novel opioid might fit into the overall therapeutic armamentarium that’s available to patients and providers, and address the question we’re frequently asked as to whether new opioid drugs should offer some comparative benefit over existing drugs. This process could include seeking revisions to statutory authorities to allow us to change the weight we give to meaningful therapeutic differentiation for proposed new opioids, including relative safety or effectiveness advantages over existing treatments.
We also plan to pursue new efforts to continue to evaluate the effectiveness of REMS programs for opioid products, including methods for data collection and assessment tools. Recently, we’ve heard concerns around the REMS program associated with one class of opioid products, transmucosal immediate-release fentanyl (TIRF) medicines, and whether the REMS program is working as intended. This is a topic that was raised by the FDA as the focus of an August 2018 public advisory committee meeting.
These products are medically important for a specific group of patients experiencing breakthrough pain that may not be managed by their around-the-clock opioid pain medicine. But these medicines also pose serious risks. That’s why the agency has sought to ensure that the TIRF REMS program is achieving its public health goal of assuring safe use and mitigating the risks of misuse, abuse, addiction, overdose, and complications due to medication errors. The agency has been actively assessing the recommendations of our advisory committee on the effectiveness of the REMS and necessary changes. Based on these recommendations, and our analysis of our own data, the FDA will soon share next steps, including modifications intended to strengthen the current TIRF REMS. The prescribing of the TIRF products has decreased dramatically from peak years in 2014 and 2015. Nonetheless, substantial risks remain if these powerful drugs are not used properly and in appropriately indicated patients. The goal of the changes we will make to the TIRF REMS programs will be to make sure the program is working to mitigate the known risks of these medicines and that these drugs are being prescribed only to opioid-tolerant patients, and that those patients understand the risks and how to use TIRF medicines safely.
Support Addiction Recovery and Reduce Overdose Deaths
To help those suffering from opioid use disorder, the FDA is prioritizing new efforts to advance the development and use of safe and effective MAT. This includes new guidance aimed at supporting the development of novel medicines as well as novel medical devices such as digital health tools, advancing new policies to promote the adoption of safe and effective MAT, and working with partner organizations/stakeholders to reduce the stigma associated with MAT.
Reducing overdose deaths also requires broadening the availability of naloxone. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren’t under the care of a physician or may fear a stigma associated with seeking access to the medicine or are fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an FDA-approved OTC product, would be an important public health advance, and a need that we’ve been working on at the FDA.
To encourage naloxone manufacturers to enter the OTC market, the FDA took an unprecedented step of developing a model Drug Facts Labels (DFL) with easy-to-understand pictograms on how to use the drug. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. These steps put into the public domain much of the regulatory work needed to take naloxone OTC. One of the key components for OTC availability is now in place so that sponsors can use it to obtain approval for OTC naloxone and increase its access. These efforts should jumpstart development of OTC naloxone and promote wider access to this medicine. This year we are seeking to work with industry partners who are interested in developing these OTC naloxone products.
Research and Innovation in Non-Addictive Pain Treatments
Another critical part of our efforts for 2019 is new steps to promote the development of drugs to treat pain that are not addictive. To advance these goals, in 2019, we’ll be issuing updated guidance outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain. We’ll also advance new steps to promote the development of abuse-deterrent formulations of opioids by exploring new methods for analyzing and evaluating abuse-deterrent features; further evaluating the nomenclature used to describe these abuse-deterrent features; and facilitating development of science for generic versions of these products.
Strengthen Enforcement Against Illicit Opioids
The FDA will continue to strengthen its enforcement activities that target those who unlawfully market or distribute illicit opioids and other unapproved drugs. We’ll step up our efforts aimed at the interdiction of opioids being illegally shipped into the United States and will continue to increase the number of investigators, both civil and criminal, in the IMFs.
Among other new steps we’ll take in 2019, the FDA is working in partnership with U.S. Customs and Border Protection (CBP) to expand information sharing and maximize each agency’s inspection and detection capabilities at the border to protect the public from illegal and potentially harmful products entering the U.S. This includes real-time sharing of data obtained by scientists using field-based screening tools to test samples that are seized at the IMFs and at the border. We’re working closely with our partners at CBP in this program.
Right now, seizures of opioids like fentanyl are typically reported in pounds of drug product seized. But that doesn’t give a full picture of the total amount of drugs that are being illegally shipped into the U.S. because these weight-based measures don’t account for potency. Some of the drugs being illegally brought into the U.S. may consist of fentanyl premixes ready for pressing into tablets, while others are super-potent formulations of compounds like fentanyl. By additional testing to develop a chemical profile of more seized samples, we can develop a better picture of the illicit drug trafficking landscape, which can better inform our policy work.
We’re also going to be expanding our collaboration with internet stakeholders to crack down on illicit drugs sold online. In April, we’re also planning our second Online Opioid Summit. The first Online Opioid Summit held last June initiated an open and candid dialogue with key internet stakeholders to discuss ways to take robust action to reduce the availability of opioids online. Since the initial Summit was announced, internet stakeholders have taken concrete steps to prevent the illegal sale of opioids through their platforms and services. Important actions came about as a result of this collaborative dialogue with key stakeholders.
For example, Google now deindexes websites based on our warning letters that cite the unlawful sale of opioids to U.S. consumers. Social media platforms such as Facebook and Instagram redirect users who are looking to buy opioids online to the Substance Abuse and Mental Health Service Administration National Helpline. We look forward to the second Online Opioid Summit to build on these efforts with additional, innovative steps to protect the public from opioids that are illegally being sold via the internet.
As part of the 2019 budget, the FDA also received $20 million to create a large-scale data warehouse to improve our analytic capabilities to better evaluate social and clinical trends that are affecting the trajectory of the opioid crisis. This warehouse can facilitate data analytics, including machine learning algorithms, to help better assess vulnerability points in the population through predictive analytics, identify early trends that may be contributing to the epidemic, and target early regulatory changes to address the changing opioid epidemic.
Finally, as part of our effort to clamp down on illicit sales of opioids – which includes our work to close down illegal portals on the internet and expand our presence in the IMFs – we’re also doing more to secure the legitimate supply chain. This means doing more to hold distributors responsible for securing the drug supply chain. As part of this effort, we recently announced that the FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corp. for violations highlighted by a concerning tampering incident that involved opioid medications. Under the DSCSA, manufacturers, repackagers, wholesale distributors and dispensers – which are mainly pharmacies – are all required to have systems and processes in place to quarantine and investigate suspect and illegitimate medications. These systems must be in place to respond rapidly to notifications of illegitimate products and to notify trading partners and the FDA when illegitimate products are discovered. The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires. This action is part of a broader policy effort to improve the security of the drug supply chain and prevent diversion of opioids. We’ll continue efforts to ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are taking measurable steps under the law to appropriately track and trace opioid medications as these products move through the supply chain, and to respond to incidents involving illegitimate products to protect the public health.
These are just some of the new steps we’ll advance in 2019 as we continue to confront this crisis. Looking back across modern times, this is perhaps the biggest public health tragedy ever created through the deliberate actions of people. The opioid crisis took hold over the course of decades of action and inaction. Now, its scope is so large, and so devastating, its toll is self-evident. It will, unfortunately, take years of aggressive action to reverse its course for good. We won’t lose our focus on this fight.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.




The opioid problem has expanded in scope along with the multiple avenues by which to treat it.  There is no 'one size' fits all approach.  As stated above the statement, education needs to be done at all levels of an organization starting with the top and working down to the orderly on a given ward.  If everyone understands the problem from their perspective, then there will be that many more tests, examination/inspections done to ensure that the emerging problem is being dealt with at various levels in various manners.



The FDA is not the only soldier in the fight.  Other federal organizations like the National Institutes of Health are funding studies to learn how to better treat chronic pain while reducing addiction to pain treatment.  Specifically, the National Institute on Drug Abuse (NIDA) has a wonderful and easily navigable web page -- click here -- with descriptions of the problems facing society around opioids, types, and videos to give a comprehensive perspective on both the problem and possible solutions to the growing crisis.



Regardless of the organization, there will always exists bureaucratic obstacles toward implementing solutions quickly on the local level.  Therefore, the crucial soldiers in the fight are of three classes: (1) health care workers (2) family and (3) community.  When healthcare workers are involved in treating/finding a solution to the opioid crisis, usually that occurs after person or persons from their communities have landed in their care in the hospital.  But as we all know, the problem started way before this.  Which is why the last two classes of people are extremely important.  Community members can help take care of the community.



If drug use is an issue, then form community groups to watch out and combat the problem.  Don't accept that the problem has to be the normal condition.  Of course, that is easier said than done.  Retaliation is a big problem -- the drug trade pays well.  Family members can offer support/care by helping their respective family members suffering from opioid addiction.



Last but not least, even though the last effort is the healthcare staff -- when the overdose patient arrives at the hospital with a critical need for care.  How the healthcare staff responds to the needs to patients who have chronic pain will determine the long term consequence of the opioid crisis.  If there is a genuine need to treat chronic pain with powerful medications, then so be it.  But the chronic pain needs of patients lay across a wide spectrum of treatment.  Which still can be optimized with new medical techniques and technology which is being developed as we speak.



The FDA will miss Commissioner Scott Gottlieb's direction after he leaves.  He has pushed the needle of progress forward on a variety of issues thus far.  He should be commended for his service.  Hopefully the remaining staff at the FDA continue to push progress on the listed agenda items in the introductory paragraphs along with the issues mentioned in the statement above from the FDA website.  There is certainly enough that the FDA can do to protect society moving forward.



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