FEDERAL INTERAGENCY COMMITTEE ON EMS SEEKS INPUT ON RFI TO IMPROVE PREHOSPITAL TRAUMA CARE

90-day public comment period is open for Request for Information to improve prehospital trauma care.

Each year, nearly 200,000 people in the U.S. die from traumatic injuries. The National Academies of Science, Engineering, and Medicine (NASEM) estimate as many as 20% of these deaths could have been prevented. The National Highway Traffic Safety Administration (NHTSA), on behalf of the Federal Interagency Committee on EMS (FICEMS), is seeking comments by July 26, 2018 on the effectiveness of current treatment efforts and opportunities to improve prehospital trauma care.

The Request for Information (RFI) seeks public input on areas in which improved prehospital care could help save lives. In 2016, NASEM released A National Trauma Care System, a report that defined preventable deaths after injury as those casualties whose lives could have been saved by appropriate and timely medical care, regardless of tactical, logistical, or environmental issues. The RFI asks respondents from all backgrounds and areas of expertise to provide input on a range of issues including opportunities for medical collaboration, EMS data integration, and the possibility of cross-training military EMS resources with civilian EMS.

Comments may be submitted:

  • Online through the Federal eRulemaking Portal (identified by Docket No. NHTSA-2018-0056)
  • Through mail or hand delivery to: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590

FDA WARNS ABOUT STEM CELL THERAPIES FROM UNSCRUPULOUS PROVIDERS

Doris Tyler lay on the examining table as the doctor stuck a long, thin tube into her belly. The doctor pulled back a plunger, and the syringe quickly filled with yellow blobs tinged with pink.

“Look at that beautiful fat coming out. Liquid gold!” one of the clinic’s staff exclaimed in a video of the procedure provided to The Washington Post.

Hidden in that fat were stem cells with the amazing power to heal, the Stem Cell Center of Georgia had told Tyler. The clinic is one of hundreds that have popped up across the country, many offering treatments for conditions from Parkinson’s disease to autism to multiple sclerosis. WASHINGTON POST

Stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what’s really being offered before you consider any treatment.

The facts: Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist. Sometimes called the body’s “master cells,” stem cells are the cells that develop into blood, brain, bones, and all of the body’s organs. They have the potential to repair, restore, replace, and regenerate cells, and could possibly be used to treat many medical conditions and diseases.

But the U.S. Food and Drug Administration is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. And the FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so that the medical industry can properly harness the potential of stem cell products.

To do your part to stay safe, make sure that any stem cell treatment you are considering is either:

  • FDA-approved, or;
  • Being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA.

Stem Cell Uses and FDA Regulation

The FDA has the authority to regulate stem cell products in the United States.

Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system.

With limited exceptions, investigational products must also go through a thorough FDA review process as investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials. The FDA has reviewed many stem cell products for use in these studies.

As part of the FDA’s review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the product’s safety, purity, and strength (potency). The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use. (You can learn more about clinical trials on the FDA’s website.)

That said, some clinics may inappropriately advertise stem cell clinical trials without submitting an IND. Some clinics also may falsely advertise that FDA review and approval of the stem cell therapy is unnecessary. But when clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe. So be cautious about these treatments.

About FDA-approved products derived from stem cells

The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood.

These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the “hematopoietic” system). These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use.

Safety Concerns for Unproven Stem Cell Treatments

All medical treatments have benefits and risks. But unproven stem cell therapies can be particularly unsafe.

For instance, attendees at a 2016 FDA public workshop discussed several cases of severe adverse events. One patient became blind due to an injection of stem cells into the eye. Another patient received a spinal cord injection that caused the growth of a spinal tumor.

Other potential safety concerns for unproven treatments include:

  • Administration site reactions,
  • The ability of cells to move from placement sites and change into inappropriate cell types or multiply,
  • Failure of cells to work as expected, and
  • The growth of tumors.

Note: Even if stem cells are your own cells, there are still safety risks such as those noted above. In addition, if cells are manipulated after removal, there is a risk of contamination of the cells.

FDA Actions on Unapproved Stem Cell Products

When stem cell products are used in unapproved ways—or when they are processed in ways that are more than minimally manipulated, which relates to the nature and degree of processing—the FDA may take (and has already taken) a variety of administrative and judicial actions, including criminal enforcement, depending on the violations involved.

In August 2017, the FDA announced increased enforcement of regulations and oversight of stem cell clinics. To learn more, see the statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA website.

And in March 2017, to further clarify the benefits and risks of stem cell therapy, the FDA published a perspective article in the New England Journal of Medicine.

The FDA will continue to help with the development and licensing of new stem cell therapies where the scientific evidence supports the product’s safety and effectiveness.

Advice for People Considering Stem Cell Therapies

Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefit—or if the product is safe to use.


If you’re considering treatment in the United States:

  • Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask the clinical investigator to give you the FDA-issued Investigational New Drug Application number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment—even if the stem cells are your own.
  • Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.

If you’re considering treatment in another country:

  • Learn about regulations that cover products in that country.
  • Know that the FDA does not have oversight of treatments done in other countries. The FDA typically has little information about foreign establishments or their stem cell products.
  • Be cautious. If you’re considering a stem cell-based product in a country that may not require regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.

Last Updated: 11/16/2017

REP. PATRICK MEEHAN(R-Pa.) RESIGNS AMID ETHICS PROBE REPORTS OF SECRET SETTLEMENT WITH STAFFER WHO ACCUSED HIM OF SEXUAL HASASSMENT

Rep. Patrick Meehan (R-Pa.) resigns amid ethics probe, reports of secret settlement with staffer who accused him of harassment

Rep. Patrick Meehan (R-Pa.), who previously announced his retirement from Congress following reports he had paid a secret settlement to a staffer who accused him of harassment, resigned outright Friday.

His resignation came as the House Ethics Committee continued a probe into his behavior that could have resulted in serious sanctions. The former aide, a younger woman, alleged that Meehan had confessed romantic feelings for her after she became involved with another man. Meehan, she alleged, later retaliated after she repelled his advances. Full Story

DISTRACTED DRIVING AWARENESS MONTH – SECONDS CAN MAKE A DIFFERENCE BETWEEN LIFE AND DEATH

 

In 2016, distracted driving claimed 3,450 lives — an 8% increase from 2014. Tragically, texting while driving has become especially problematic among millennials, particularly female drivers who have been more likely to be involved in a fatal crash every year since 2012.

Whether you are on the phone, texting, checking your hair, or reaching down for a burger and fries, you are robbing yourself of seconds that can be the difference between a close call and a deadly crash.

Regardless of the law in your state, you should be asking yourself, “What can I do? And how do I keep my family safe?”

Distracted Driving Awareness Month is a great time to reflect on the choices that you make while behind the wheel and to take action in your community to help stop distracted driving.

Join us on April 30 from 7 a.m. to 11:59 p.m. as we tweet every 30 minutes about the dangers of distracted driving. One conversation, one share, or one retweet could save the life of a loved one. Take the pledge to drive safely and talk to your friends and family about doing the same. Join us in our fight for safer roads.

Who: NHTSA and You!

What: #JustDrive Tweet Up

When: Monday, April 30, 7 a.m. – 11:59 p.m. ET

Where: http://www.twitter.com/NHTSAgov

How: Follow the conversation using #JustDrive. Feel free to mention @NHTSAgov in any of your tweets and we will return as many questions and comments as we can!

 

 

 

SOUTH DAKOTA ATTORNEY GENERAL JOINS 20-STATES INJUNCTION AGAINST OBAMACARE

PIERRE, S.D. – Attorney General Marty Jackley confirms that South Dakota has joined a 20-state coalition in a motion seeking a preliminary injunction against the federal government’s Affordable Care Act (ACA).

“South Dakotan’s deserve more affordable health insurance than mandated Obamacare has provided. Compliance with the mandatory provisions of Obamacare has resulted in documented costs of over $28.7 for the State of South Dakota and additional insurance premiums for citizens,” said Jackley. “The original 5 to 4 Supreme Court decision was based not on healthcare but on Congress’ decision to tax us, and it is time to once and for all end this federal mandate to allow medical doctors more freedom to care for patients and private industry to compete for lower insurance premiums.”

The motion for a preliminary injunction against Obamacare is necessary to spare the states from the enormous financial burden caused by the individual mandate.

Before Obamacare, “the states allowed individuals to determine whether to buy health insurance, established high-risk insurance pools to help individuals in ill-health, enabled cost-sharing, and instituted many other policies that Obamacare now preempts or functionally preempts,” the coalition wrote.

Texas and Wisconsin are joined in the lawsuit against Obamacare by the attorneys general of Alabama, Arkansas, Arizona, Florida, Georgia, Indiana, Kansas, Louisiana, Missouri, Nebraska, North Dakota, South Carolina, South Dakota, Tennessee, Utah and West Virginia, along with the governors of Maine and Mississippi. View a copy of the motion seeking a preliminary injunction here: https://bit.ly/2HuVcNH

DEMAND MIKE PENCE CANCEL HIS SPEECH TO THE NRA CONVENTION IN DALLAS TEXAS MAY 4, 2018

“Mike Pence is scheduled to speak at the NRA convention in Dallas on May 4. This is a slap in the face to Americans—from Parkland to Chicago to Nashville—hurting from gun violence. It’s also a signal to young people organizing historic actions that the NRA’s extremist agenda and donations are more valuable to Mike Pence than the lives lost. Sign now to demand Mike Pence pull out of the NRA convention.”

Despite some of the most shocking mass shootings in American history, Mike Pence thinks it’s a good idea to be a headliner at the NRA’s convention in Dallas on May 4. It’s scheduled to take place just days after police officers were critically wounded by a suspect at a Home Depot right there in Dallas.

It’s sad that Pence is so dismissive of the American lives lost in Las Vegas, Sutherland Springs, and Parkland—not to mention the thousands of people killed every month by gun violence.

The majority of Americans want politicians to stop gun violence with common sense reforms. But rather than using his platform to advocate for peace and common sense safety, Mike Pence is rewarding extremists in the NRA.

Trump, Pence, Ryan, McConnell, and the rest of the GOP seem happy to continue making excuses for gun violence because the NRA throws millions of dollars at their party.

Enough! We must hold all politicians to basic standards of decency.

Tell Mike Pence to drop out of the NRA’s convention and stand with the majority of Americans who want real action to end gun violence.

The above link will take you to the moveon.org website.

SDDA Classifies Dicamba Products as Restricted Use Pesticides

 

PIERRE, S.D. – As of April 30, 2018, all pesticide products containing only dicamba, and having agricultural use labels, sold in South Dakota are classified as restricted use pesticides (RUPs). This includes over-the-counter herbicides that were previously sold to unlicensed applicators and producers. Since these products have been classified as RUPs by the State of South Dakota, but not by the federal government, they will not display the restricted use pesticide legend on the label. A list of 2018 registered products impacted by this new classification can be found on the South Dakota Department of Agriculture’s (SDDA) website, sdda.sd.gov, by clicking on the “Dicamba Information” link under the “Happening Now” section.

Applicators will be required to be certified private or commercial applicators to purchase and apply these products. In addition to state certification, the SDDA encourages applicators to take a dicamba-specific training. An online training is available on the SDDA’s website. All applicators will be required to maintain application records for each application of these products and any other RUPs. The records of application must be kept for three years.

Three dicamba products, Xtendimax with Vapor Grip technology, Fexapan with Vapor Grip technology and Engenia, were classified as RUPs by the Environmental Protection Agency effective October of 2017. Separate regulations surround the sale and use of these products, including a requirement that applicators complete a dicamba-specific training.

Any questions about this change or the regulation of dicamba products can be directed to the SDDA at 605.773.4432.

EMBRACING CHANGE

 

Embracing Change. Photo: NASA

 

By Peg Ryan
Mile High Pilates and Yoga

We are all temporary residents of Planet Earth and none of us knows when our visa will expire.  Despite the fact that this is the one certain fact of our existence, we spend our lives either resisting or, mostly, ignoring it. Hoping it will just go away.  Or maybe somehow we will miraculously be exempt.  Of course, no one wants to dwell on the fact of his/her own demise even though it is inevitable.  Our society has an uncomfortable relationship with this concept.  Some of us have beliefs about what happens after death that subdue negative thinking on the subject.  But mostly what we think of when we reflect on the impermanence of life is it’s loss.  And it’s not just people but every living thing on the planet that will undergo the transformation from life to not-life, whatever that entails.  Those left behind lose someone or something, creating a void where that living being once was.  Those about to move into the transition will lose everything that is familiar, the perceptions that a lifetime of consciousness has provided.  They think of all the events they will miss.  So it’s not really death that we worry about.  Of course, we may fear the potential pain that might accompany death.  But what we really fear is loss.  And change.

No one likes change.  Yet change is as inevitable as death.  Everything is changing all the time, and despite our best efforts, there is nothing we can do to stop it.  Even when we think we’ve managed to head off certain changes, other changes will still occur that may not have been anticipated.  This is not to say that we shouldn’t work to make changes that could improve our lives.  But outcomes will most likely be different from what we expected when we began this work. Unexpected things happen all the time.  This is why many thinkers on these subjects recommend focussing on the process, rather than the outcome.  There’s an old Yiddish saying, “Man plans and God laughs”.  Life is unpredictable.  Pay attention to the journey, but let the chips fall where they may.

Loss comes in many forms, not just the ultimate.  Often we fail to acknowledge the significance of other losses in our lives.  Sometimes we know they are coming, other times we don’t.  Either way, we don’t always have a choice in how things work out.  We lose jobs, homes, money, youth, independence, etc., etc.  Even when we think we’ve chosen well, there are many factors beyond our control.  Sometimes things work out the way we want, sometimes they don’t.   It’s so easy to judge the actions of others.  Or to beat up on ourselves when we think we’ve made some huge blunder.  Hindsight is 20-20.  But most of us do the best we can with what we have to work with at the time.  And time only moves in one direction.  There is no going back.  What exists right now is what we have to work with.  We can’t change other people.  Circumstances beyond our control create situations that can’t be changed.  Sometimes we can change parts and pieces or maybe work toward a change.  But for the most part the only thing we can change is our attitude and perception.

In an article in Yoga Journal author Sally Kempton talks about navigating through change.  She cites “the Buddhist Doctrine of Impermanence, annica, [which] tells us that change is inevitable, continuous, and unavoidable.”  There is also a way of viewing this as the constantly shifting nature of energy:

“the intrinsic, dynamic power at the heart of life. . . . Every moment, every enterprise, every cell, is part of this flow of creation, sustenance, and dissolution. This flow is happening on a macrocosmic level—as the flow of seasons, tides, and cultures—and on a microcosmic level, through the various shifts in your physical states, the ups and downs of your life, and the flow of thoughts and emotions in your mind.”

When seen this way, even the most determined control freak must acknowledge that these changes are happening right before our eyes in every moment of every day.  Like it or not.

Perhaps instead of thinking of “endings” and “beginnings”, we can think of change as heralding transformation.  Part of our fear of loss is fear of the unknown.  What will be on the other side of this loss?  We know what life was like before the change.  How will we deal with what comes next? Even if the current state of affairs is not optimal, at least it’s familiar – the “devil you know “.  In the article cited above, Ms. Kempton also talks about ritual.  She writes, “In traditional societies, every phase of life was regarded as an initiation into a new way of being and was marked with a ceremony. . . Nowadays, we don’t always do a ceremony, but we still undergo initiations.”  All life changes require us to “step outside your habits, test your skills, and, for a time, inhabit the unknown. . . Each of these changes will subtly or even dramatically redefine you. You won’t be quite the same person after you step out of the old situation and into the new.”  Furthermore, “the change itself . . is the doorway into the next stage of growth—one that propels you into a deeper relationship with yourself and the world.”

The article goes on to provide some ideas for moving through change gracefully.  These, of course, require practice. Practice implies that success is not guaranteed, but there will always be another opportunity to try.  There are many articles and numerous suggestions from all kinds of authors on what to include in such a practice.  Everyone needs to find what works for them.  Still when change is sudden and catastrophic, it can be difficult to remember how to practice, let alone recognize that you are embarking on a new way of life.  Mourning is also a ritual.  Recognizing loss and the need to mourn is just as important as accepting change.  But all suggestions seem to boil down to the same concept:  leave the past behind, let the future take care of itself and simply be here now.  In this moment.  Hear your breath.  Count your blessings.  If you’re still a resident on the planet with an unexpired visa there will always be something to be grateful for.  Loss hurts.  It’s OK to hurt.  It’s part of being human.  Allow it.  Be kind to yourself.

MORE REASONS FOR SELF-COMPASSION

 

Photo: Angelac72/Pixabay.com

By Peg Ryan
Mile High Pilates And Yoga

Does kindness matter?  This simple question is central to a recent article in Diabetes Spectrum highlighting research revealing the health benefits of self-compassion.  According to the article “Self-compassion is defined as the practice of treating oneself with kindness, care, and concern in the face of negative events.”  The article goes on to state that “self-criticism, a common consequence of self-care failure . . . can be seen as the opposite of self-compassion”.  Although this article focuses on the effects of self-compassion and its absence on diabetes patients in particular, it is clear that these health concerns can be more broadly generalized.  The article cites “A series of experimental studies suggest[ing] that quantifiable physiological and neurological processes underlie the experience of self-compassion.”  Furthermore, “consistent evidence suggests that self-compassion is related to physical and psychological health”.  As an example, “in a study [see citation below]* in patients with obesity and pain problems, self-compassion predicted lower negative affect, higher positive affect, more adaptive pain coping, higher pain self-efficacy, and lower pain catastrophizing.”

Not surprisingly, the opposite has also been shown to be true.  For example, ” the opposites of self-compassion, including self-criticism, self-hate, self-judgment, and negative perfectionism, have been linked to greater psychological distress, including depression.”  The article is full of additional confirmations, citations and examples of the positive health effects, both physical and psychological, of self-compassion and the related negative consequences of its deficiency.

An article in the Washington Post that refers to this research also cites a book by Kristin Neff titled “Self-Compassion: The Proven Power of Being Kind to Yourself”.  In it, the author speaks of the three elements of self-compassion:

  • Self-kindness – the ability to be understanding with yourself rather than judgmental or harshly critical;
  • Common humanity – the recognition that none of us is perfect and all of us make mistakes, thus viewing ourselves as part of the human experience;
  • Mindfulness – the ability to pay attention to the present moment, neither dwelling on the past nor excessively worrying about the future.

If you’ve been following this blog, you may recognize these themes.  In fact, a very recent post discusses the benefits of self-care which are obviously closely related to self-compassion.  The articles referred to here also talk about the ways in which we sabotage ourselves.  For example, some of us may believe that being kind to ourselves needs to be secondary to taking care of others.  Think about that:  how can you give others something you are unwilling to give to yourself?  Furthermore, the consequences of denying ourselves the compassion that we wish to share with others can be pretty dire.   From the Washington Post article: “The opposite of self-compassion is emotional reactivity, isolation, self-judgment and unhealthy perfectionism, all of which have been linked to depression, stress and reduced quality of life.”

These ideas are echoed in an article in Health Psychology Open.  It states that “Substantial evidence supports the idea that self-compassion
can reduce perceived stress”.   Research findings show that  “people who have higher levels of self-compassion tend to handle stress better — they have less of a physical stress response when they are stuck in traffic, have an argument with their spouse or don’t get that job offer — and they spend less time reactivating stressful events by dwelling on them.”  Since chronic stress has direct effects on all aspects of our health, this is no small thing.  Additional research is also cited in this article indicating that people with higher levels of self-compassion are more likely to start and adhere to healthy behaviors which further enhances the benefits.  In other words, self-compassion promotes better health which contributes to better feelings about oneself which enables more self-compassion.  Conversely, negative self-care leads to poorer health which takes one’s self-image in a downhill spiral in the opposite direction.

So next time you’re tempted to run yourself down for any reason, it might be worth remembering that berating yourself may be more than just a temporary mood darkener.  It just might have more serious negative health ramifications that could be avoided with a little kindness.  Isn’t that simple step worth the effort?  Try noticing those negative thoughts.  Maybe you can remind yourself that “to err is human, to forgive, divine”.  Our world would be a safer and healthier place if we all practiced a little more kindness.  You can start that practice with yourself.  If you want to treat other people well and you want other people to treat you well, you can set an example by treating yourself well, too.  Your health care practitioners will applaud!

 

* Wren A, Somers T, Wright M, Goetz M, Leary M, Fras A. Self-compassion in patients with persistent musculoskeletal pain: relationship of self-compassion to adjustment to persistent pain. J Pain Symptom Manage 2012;43:759–770