PREVENTABLE TRAGEDIES

The horrific murders of Rob Reiner and his wife, Michele, by their son are made more tragic because they were preventable.

Nick Reiner, Rob’s son, began his downward spiral to murder at age 15.  His eighteen attempts at failed rehabilitation are typical of the 1.36 million patients going through Rehabilitation Programs to address their Substance Use Disorder (SUD).

Drug Rehabilitation is now a $35 billion global industry.  Americans spent $9.44 billion on patient rehabilitation treatments in 2024.  U.S. Rehab spending is expected to rise to $16.22 billion by 2033.  Another $1.5 billion is allocated in Federal grants for Opioid Response Programs.

Approximately 60 percent of those who complete rehab programs relapse into addiction. Only 43 percent of those who enter rehab programs complete their treatment.

These multiple levels of failure have only motivated government and private foundations to spend more money pursuing the same approaches.  How many more lives will be lost before there is meaningful change?

It does not have to be this way.

On November 4, 2022, the Centers for Disease Control (CDC) issued their updated Opioid Prescription Guidelines.  Their goal was to limit the exposure to Opioids when health professionals manage pain.

They unanimously recommend the use of Red-Light treatments as the preferred nonopioid therapy for chronic pain.  They also declared that Red-Light therapies were as effective as opioids for common types of acute pain.

Red-Light, known in the scientific literature as Photobiomodulation (PBM), has treated over 100 million patients in clinical settings without any documented side effects.  

PBM Therapy’s efficacy is supported by 2,466 Randomized Clinical Trials (RCTs) and 11,178 research studies, many published in leading scientific journals, including the Journal of the American Medical Association (JAMA) and the Lancet.  

There are 505 active PBM clinical trials registered with the National Institutes of Health (NIH).

PBM has been proven to improve the success rate of SUD rehabilitation. PBM eases the physical and psychological withdrawals from opioids and other drugs.  It dramatically reduces relapse.

Major studies have documented PBM’s role as an effective adjunct to traditional drug rehabilitation.

In 2020, Dr. Fredric Schiffer, Harvard Medical School, proved PBM reduced Opioid cravings by 51% versus 15.8% using traditional rehabilitation.

A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham - PMC

In 2024, Dr. Jennifer Flora, Shepherd University, validated Schiffer’s findings.  She further documented a significant reduction in depression symptoms. Dr. Flora’s depression findings validated earlier studies conducted at Harvard Medical School by Dr. Michael Hamblin and Dr. Paolo Cassano.

Transcranial Photobiomodulation Therapy as an Intervention for Opioid Cravings and Depression: A Pilot Cohort Study - Jennifer Flora, Kelly Watson Huffer, 2024

What is Red-Light/Photobiomodulation?

Photobiomodulation (PBM) is a noninvasive, FDA cleared, medical technology that successfully manages pain and treats a variety of medical conditions.

The human body has 32 trillion cells.  Each cell has thousands of Mitochondria that process nutrients and light into the energy required to power the cell.  When we are injured, ill, or aging, this process breaks down, harming the cell and the body. Exposing all or part of the human body to intense Red and Near-Infrared light restores the Mitochondria’s ability to generate cellular energy.

PBM is a natural process aiding a natural process. 

Why is Red-Light/Photobiomodulation not generally available to those in need?

Bureaucratic inertia is preventing this proven treatment from being known and adopted:

-       The Centers of Disease Control (CDC) has never added its PBM therapy recommendations to their updated Opioid Guidelines media pages or educational material.

      CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 | MMWR

-        The Substance Abuse and Mental Health Services Administration (SAMHSA) has never added PBM treatments to its rehabilitation recommendations. 

-       The Food and Drug Administration (FDA) has never published an updated and accurate description of PBM for expedited device clearance, even though the final rule process was completed in March 2023.

      Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions | FDA

-       States dispersing Opioid Settlement money continue to purchase Naloxone EpiPens and fund failed rehab programs.

The Make America Healthy Again (MAHA) movement, President Trump, and HHS Secretary Kennedy, should take immediate action to implement these life-saving approaches that have already gone through extensive scientific and regulatory vetting.

No one suffering from Substance Use Disorder should ever have to go through Nick Reiner’s ordeal.  No family member should be murdered because the rehab system refuses to pursue successful treatment options.

 

LIGHT THERAPY GOING MAINSTREAM

 

Shepherd University | PBM Home

Many medical procedures that are now commonplace were once novel and experimental.  One example is Magnetic Resonance Imaging (MRI).  When a doctor tells you, “We need to do a MRI” you say “Okay” and the insurance company you use says “Okay” without a second thought.  Most patients do not even remember what “MRI” stands for.  It is just part of a normal diagnostic process.

The underlying concept of MRI was discovered in 1945.  MRI was first used in 1974.  A whole-body MRI scanner was developed in 1977.

The Photobiomodulation Foundation is attempting to make “PBM” the next “MRI”.

There are many challenges.

Dr. Endre Mester, a medical researcher in Budapest, Hungary, discovered the PBM effect in 1967.  His ground-breaking discovery remained little known for 22 years, until the fall of the Berlin Wall in November 1989.  PBM papers began being published in the West in 1990.  Their acceptance suffered from wide-spread skepticism of research conducted behind the “Iron Curtain” of Communist run countries.  PBM also suffered from researchers, inventors, and practitioners creating a plethora of terms describing the same effect, making it difficult to track studies and trials.

PBM’s many applications, devices, and manufacturers created a “wild west” where consumers are overwhelmed with terminology, product claims, and company marketing. Limited anecdotal evidence is comingled with validated clinical trials while the 9,000+ published papers range from world class seminal works to poorly written and fragmentary essays.  This cacophony is daunting to all.

PBM is segmenting into Medical Grade devices that are used in clinical settings, and Consumer Grade devices (usually called Red Light Therapy) that are used by individuals in their homes.  There are also trends away from LASERS to LEDs and employing higher light wave lengths (the traditional 500-900nm spectrum is pushing toward 1200nm).

The PBM marketplace is getting more complex as Medical Grade devices are now being used in home settings and being self-administered.  Medical Grade devices are being used for cosmetic purposes, and Consumer Grade devices are being used for treating medical conditions.

While PBM’s popularity is expanding its benefits to a wider population, it is creating a “buyer beware” environment.  Trust among health professionals and consumers is vital to PBM becoming an accepted mainstream biotechnology. 

Leading PBM researchers wrestled with these multiple challenges.  A series of meetings resulted in the Photobiomodulation (PBM) Foundation being founded in December 2017. There were already the North American Association for Laser Therapy (NAALT) and the World Association for Laser Therapy (WALT), along with the oral health focused, Academy of Laser Dentistry (ALD). These organizations perform the invaluable role of sharing research and application among PBM professionals. The PBM Foundation was to be different by being more outwardly focused in communicating and partnering with policy officials, political leaders/influencers, media, and stakeholders.

The PBM Foundation’s first task was becoming “bi-lingual”.  This meant translating impenetrable research papers, that were filled with five-syllable terms, into lay audience messaging that directly related and resonated to the interests of decision makers and influencers.

Another challenge was to focus the wide array of PBM’s health impacts to a critical few, which had the strongest clinical evidence and highest impact on public health.  The first three were (1) preventing side effects of cancer treatment, especially Oral Mucositis; (2) Pain management, as it relates to addressing the Opioid crisis; and (3) treating Veterans for neurological conditions, physical therapy, and wounds. 

October 11, 2018 was the PBM Foundation’s “curtain raising” event – a formal Congressional Briefing on Capitol Hill focused on how PBM’s successful management of pain could address America’s Opioid crisis.  This was followed by formal testimony before various Opioid and Pain Management task forces within the Federal Government.

Media outreach generated mainstream news coverage of PBM successfully managing pain and preventing Oral Mucositis.  The University of Pittsburgh Medical Center, the West Virginia University Cancer Institute, and St. Jude’s Children’s Hospital formed an echo-chamber of high profile stories on PBM’s life-saving impacts.

Veterans’ hospitals began using PBM to treat their neurological patients, led by a partnership with Boston University.  Ten other VA medical centers adopted PBM for physical therapy and healing wounds.  Political support for Veterans generated Congressional endorsement, showcased by Rep. Jim Hagedorn’s and Rep. Alex Mooney’s Keynote addresses at PBM2021.

Another PBM Foundation initiative is a pilot Equipment Testing program.  The goal is to provide an independent review of a product’s operation relative to its claims.  This information will allow consumers of medical equipment to make medically and fiscally responsible equipment choices.  The goal is to build trust among consumers by verifying viable products in a crowded and confusing marketplace.

The PBM Foundation draws much of its inspiration from hundreds of industry associations, which provide vehicles for competing companies to find common cause, while improving the professionalism of their industry.  This unity of purpose will be the final element in making the application of PBM the next MRI.

FIRST CENTER OF EXCELLENCE FOR LIGHT THERAPY

 

Shepherd University | Center of Excellence for Photobiomodulation at Shepherd University

On March 21, with national and state officials attending, Dr. Mary Hendrix, President of Shepherd University formally inaugurated The Center of Excellence for Photobiomodulation (PBM).

 

The ceremony was the culmination of many years of work.  It was an historic moment for the PBM movement.

 

During the October 2017 PBM Strategic Planning Session, the Center of Excellence was a key priority, along with establishing the PBM Foundation and a testing program.  It was deemed important that the PBM movement had a formal “home” from which to build collaborative relationships with scientists, practitioners, and industry while attracting the resources needed to take PBM mainstream. 

 

The Center of Excellence for PBM will become the framework for aggregating, curating, and disseminating information on discovery and application of this biotech breakthrough.

 

Shepherd University was the Center of Excellence’s logical location. Shepherd University’s School of Nursing was the first in the world to formally incorporate knowledge and use of PBM into their graduation requirements.  Its 400 nursing students interact with PBM’s top researchers while gaining “hands on” experience using the most advanced PBM medical devices.  Shepherd’s PBM adjunct faculty is a “who’s who” of global experts.

 

President Hendrix also made Shepherd a logical location.  She is a leading scientist in cancer research, writing more than 280 published papers on biomedical research and serving on national boards relating to health policy and medical innovation.

 

This natural alignment was further augmented by relationships with PBM supportive medical and research facilities.  These include the Martinsburg Veterans Health Center, one of the largest in the nation, the Mountaineer Recovery Center, the National Conservation Training Center, and the U.S. Department of Agriculture’s Research Center.

 

In July 2019, the West Virginia state government recognized Shepherd’s leadership role with a $2.7 million grant to address rural health and use PBM for managing pain to reduce Opioid use.  West Virginia remains America’s epicenter for Opioid addiction and deaths.

 

In December 2021, the Governor of West Virginia allocated $500,000 under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) for establishing the PBM Center of Excellence order to, as the Governor announced, “develop cutting edge technique that manages pain and does so many different things that could very well be a breakthrough in the COVID situation.”

 

“The Center’s vision is to universally improve health and wellbeing by using the science of PBM and its devices to deliver therapies to speed recoveries from injury and illness,” said Dr. Jennifer Flora, Shepherd’s Director of PBM Wellness. “We are in the business of changing lives for the better. Our goal is to help people thrive using innovative technology and it starts today at the Wellness Center with convenient PBM services for our campus and surrounding community.”

 

Dr. Praveen Arany, the PBM Center of Excellence’s Interim Executive Director, said the Center’s three core goals are to “focus on wellness, explore deaddiction to opioids, and treat long COVID-19 symptoms”.

“A lot of people have had COVID-19 and as they are recovering, we are finding things like fatigue, depression, and chronic diseases, which are causing concern,” Arany said. “We would like to use this innovative treatment that is nonpharmacological and noninvasive and focuses on the host’s resilience. We are trying to make people healthier and better.”

The Center’s launch lays the groundwork for further progress on the science and application of PBM and educating the public about the benefits of this revolutionary treatment.