Oct. 27, 2023

Former Congressman Al Wynn

(TriceEdneyWire.com) - In state legislatures across the country the “right to repair” movement is gaining momentum. Thirty-three states and Puerto Rico considered right to repair legislation during the 2023 legislative session. And while this might be a good idea for some products, policymakers should oppose any attempts to weaken regulated safety requirements for repairing life-saving and life-enhancing medical devices. Patient safety is too great a risk.

In theory, expanding repair options might seem like a good idea. It is the democratization of product repair. And certainly, there are many industries in which this is the right path forward.

In fact, advocates for this movement notched a symbolic win in California after tech giant Apple unexpectedly supported a bill that would require electronics companies to provide more access to the parts and instructions to fix their products.

What the right to repair movement ignores though is that not all product classes are created equal. And a one-size-fits-all solution is not a real solution, especially when it comes to regulated products like medical devices.

Medical devices are an important part of the healthcare services industry. Every single person has been helped by a medical device – whether it’s an EKG machine, a defibrillator, dialysis pump, x-ray machine, or any of the other more than 24,000 devices that medical professionals use every day.

Now imagine if that device didn’t work.

It is this risk that should give policymakers considering these right to repair laws pause. Given the influence medical devices have on public welfare, do we really want to introduce more risk? Risk that could impact functionality?

During my time in the House of Representatives, I served on the Subcommittee on Health whose jurisdiction included oversight over the U.S. Food and Drug Administration (FDA), the agency in charge of the effective regulation of these devices to guarantee their quality and safety. I know firsthand the diversity and sophisticated nature of these products. By granting broad, open access by repair shops unregulated by the FDA, we could be undermining device integrity maintained by the whole regulatory system. 

Essentially, if a smartphone or tablet malfunctions from a bad repair job, there’s sure to be some headaches, but you’ll survive. On the other hand, if a sophisticated medical device experiences the same type of error because a hospital chose unregulated repair options, it can be a matter of life or death.

It is also important to consider possible unintended consequences this type of policy might have on underserved and racial minority communities, which are most often among the truly disadvantaged.

One report from researchers with UCLA, Johns Hopkins and Harvard shows that hospitals with a large share of African American patients have significant funding disparities and receive lower payments for care from programs like Medicare. Unfortunately, these facilities are the ones that will most likely use the unregulated repair option to fit necessary maintenance into tight budgets. Therefore, we could be unintentionally putting our community on the front lines of the increased risk a broad right to repair policy would enable.

Cutting corners in the medical field should never be an option. A 2016 study by the National Library of Medicine found that cutting corners was a “common practice” that contributes to adverse outcomes. That’s simply unacceptable.

Albert R. Wynn is a former member of the U.S. House of Representatives, representing Maryland’s 4th Congressional District. While in the House, he served as a member of the Subcommittee on Health. 

May 6, 2023

(TriceEdneyWire.com) – I am blessed to have friends in every walk of life.  With few exceptions, when I speak with friends who are combat veterans and ask about their emotions in a combat zone, they speak of a heightened sense of awareness and almost paranoid preparedness for averting threat or danger, 24/7/365.

Many servicemembers can survive a combat tour without lingering affect, but the constant intensity of emotions or traumatic exposure to danger and/or injury has caused many to suffer with Post Traumatic Stress Disorder, PTSD.  I do not minimize the impact of PTSD, but I have and still wonder why so many are unwilling to compare and contrast the stress and trauma of a combat tour with a lifetime of stress and trauma in an under-served and over-policed/regulated community.  Although I am not a mental health professional, I see the reality of PTSD in both experiences, with a greater likelihood of manifestation in the latter.

May is Mental Health Awareness Month and it is appropriate to discuss such issues.

In the past I have referenced Maslow’s Theory of Hierarchy of Needs.  Maslow asserts that self-actualization – higher order thinking/reasoning - cannot occur until the most basic survival needs are met, but few talk about what happens whether or not, or while survival needs are being sought.  I submit that the lack of any life sustaining/improving commodity is genuine cause for post-traumatic stress – what I equate to internal violence.

Absent depth and detail, I would like for you to imagine the constant internal conflict and mental upheaval trying to rear children or living in/under the described circumstances:

·        Living in an unending cycle of insufficient income.  “Juggling” money to pay essential bills, often losing a utility, or missing or watching your children miss meals.  Common to my own DC Metro area are professionals working two jobs to bridge the gap of economic insufficiency between fulltime incomes and poverty. 

·        Living with the knowledge that an unexpected toothache, illness or injury offers a real threat to the life and welfare of the affected individual AND family financial security.

·        Having to give your children “The Talk” indicates a monumental fear for their survival into adulthood.  Wondering and fearing (whether) “you” will be the next parent informed that your child has met an untimely death at the hands of street violence – “legal” or otherwise.

·        Substandard housing which endangers the life, limb, health, property, safety or welfare of the occupants.  Whether in a state of near-dilapidation, disrepair, with insect or vermin infestation, these structures, however familiar to the residents, impose undue stress.

·        Environmental racism of neighborhoods populated primarily by people of color and members of low-socioeconomic backgrounds —burdened with disproportionate numbers of hazards including toxic waste facilitates, garbage dumps, and other sources of environmental pollution.  The absence or lack of drinkable water in Flint, MI and Jackson,  MS, as well as, environmentally volatile locations like New Orleans’ Lower 9th Ward which, after eighteen years, still suffers the ravages of Hurricane Katrina, are clear examples of environmental racism and a constant threat to the health and well-being of communities of color.

These issues only scratch the surface of the unending challenges facing those least likely to possess the resources to overcome them.  For many, these daily challenges are intertwined into a mesh of priorities that only make room for survival.  For too many, thoughts of addressing social isssues like defending voting rights, reforming the criminal justice system, expanding access to affordable healthcare, closing the racial wealth gap, advancing affordable housing, and a myriad of other problems of social injustioce become secondary.

As with our history in this nation, seeking good health seems insufficient.  We must fight vigorously to overcome the ravages of poor health.

(Dr. E. Faye Williams is President of The Dick Gregory Society, thedickgregorysociety.org and President Emerita of the National Congress of Black Women) She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it.).

March 14, 2023
By Hazel Trice Edney

NEWS ANALYSIS

(TriceEdneyWire.com) - It’s an unfortunate truth that over the course of our nation’s history, progress has often come at the expense of Black and other racial minority communities. From heavy manufacturing to busy rail lines, too often, communities of color are expected to pay more than their share of the cost of development.

The ongoing fallout from last month’s derailment of a Norfolk Southern train carrying toxic chemicals in East Palestine, Ohio illustrates in no uncertain terms just how crucial the question of environmental justice is to the future of rail safety in America.

 This writer has reported multiple concerns in past columns that a pending merger between two large railroads—Canadian Pacific and Kansas City Southern—would be the next example of minority communities being asked to bear the brunt of development. New comments submitted to the U.S. Surface Transportation Board (STB) by the Environmental Protection Agency (EPA) have only added fuel to that fire.

Regulatory agencies aren’t typically known for their brevity. So, in its paraphrased comments to the STB, the EPA suggested that those reviewing the merger proposal conduct further analysis to determine the “disproportionate adverse impact the proposed acquisition would have” on poor neighborhoods – also known as environmental justice communities.

Put another way, the EPA is worried that this proposal will—like so many that came before it—have a greater negative impact on minority communities than on the nation at large.

This simply isn’t right. It wasn’t right before disaster in East Palestine, and it feels even more negligent now in the face of such clear evidence of the stakes of the rail safety debate.

The primary adverse impact identified by the EPA in its analysis of the environmental impact statement (EIS) prepared by the STB was noise. Certainly, noise is no small concern. Those living in communities adjacent to busy freight rail lines can attest to the disruption that comes along with a massive train rattling windows at all hours. But noise isn’t the only consideration. Minority communities adjacent to the Canadian Pacific/Kansas City Southern lines would face a host of other impacts, from poor air quality to increased congestion and reduced emergency response time due to traffic at crossings.

The stakes have only grown higher following the East Palestine tragedy. The nation has seen what can happen to communities along rail lines. The risk of an incident has always been there, but that risk feels significantly more tangible in light of the images of dark chemical clouds looming above a small town in Ohio.

What’s more, one of the local elected officials in East Palestine recently wrote to the STB urging concern over the merger’s impact on the movement of hazardous materials across the country noting that the proposed acquisition would result in a staggering two million additional tank cars moving on the nation’s rail lines filled with the same hazardous materials that derailed and created such an environmental calamity in Ohio.

Minority communities shouldn’t be expected to simply accept these risks. The EPA is clear: More study is needed to determine just how severe the impact on environmental justice communities tied to this acquisition would be.

There’s a reason so many concerned observers have spoken up in opposition to this proposal. From local officials in Houston, Texas, and Ohio to Senators Elizabeth Warren, Dick Durbin, and Tammy Duckworth, the acquisition has sparked concerns about safety and competitiveness. The Department of Justice even wrote in opposition due to concerns associated with anti-trust laws.

Freight rail is, without question, crucial to the overall economic health of the U.S. But focus on economic health should not come at the expense of focus on the health of minority communities.

There is no doubt that supporters of this acquisition would prefer to move quickly. Those seated in board rooms rarely welcome calls for further study and analysis. But, to those who live and work along the rail lines in question—the idea of rushing approval of such a project is difficult to comprehend.

The STB should listen to the EPA, the DOJ, members of Congress and those on the front lines of the disaster in Ohio. Rushing approval benefits few outside of the aforementioned board rooms.

Further study could very well save lives.

Feb. 14, 2023

Lawrence Davis, a U. S. Airforce veteran, credits prostate cancer treatment at Hampton University, an HBCU, for saving his life after the Veteran's Administration refused to pay for the therapy.

 

By Hazel Trice Edney

(TriceEdneyWire.com) - The benefits of Historically Black Colleges and Universities (HBCUs) are well known by those who enroll in them, support them or otherwise associate with them.

Among the top five benefits, according to the United Negro College Fund, HBCUs meet the needs of low-income students; they serve first-generation Black students; they narrow the racial wealth gap; they address the nation’s unemployment and underemployment crisis and they foster success with their Black cultural climate.

But, in the opinion of Lawrence Davis, a master mechanic who was diagnosed with prostate cancer nine years ago, an HBCU actually provided for him a service that was equal to or even greater than any one of these benefits. Davis credits Hampton University for literally saving his life after the Veteran’s Administration declined to pay for his chosen cancer treatment – Proton Beam at Hampton University.

“I’ll tell anybody!” Davis declared during an interview. “Hampton University’s Proton Therapy Cancer Institute saved my life. It’s like the best kept secret in the world that we have right here in Virginia. And it is the largest stand-alone and most advanced one in the world – not just in Virginia, but in the world.”

But, that 2014 victory did not come without a fight. The fight was not as much against the cancer per se as it was with a least expected opposition.  Despite the fact that Davis is an honorably discharged veteran of the U. S. Air Force, he recalls how the Veteran’s Administration (VA) refused to cover the cost of the proton beam therapy, thereby putting his life in jeopardy.

“‘We’ll cut it out, we’ll give you radiation, we’ll freeze it, but oh no – proton? – uh uh. We can’t give you that,’” he recounted his perception of the response from the VA.

But, his mind was made up. Therefore, the fight was on.

He reached out to Bill Thomas, associate vice president for Governmental Relations of the Proton Therapy Institute and other Hampton University leadership. They, in turn, started going around back and forth with the Veteran’s Administration, he said.

“Bill Thomas has gone out and handed them everything that we can hand them. And they still turned it down,” said Davis.

They also reached out to members of the U. S. Congress; including Virginia Sen. Tim Kaine; Sen. Mark Warner and Rep. Bobby Scott.

“And still the VA said, ‘No we’re not going to do that.’ They wouldn’t even look at it to be able to do it as a clinical trial,” Davis said.

Thomas recalls the frustration that was all too familiar.

During a meeting led by Scott, “I literally asked the VA, “Why are you letting this man die? Why are you not giving him what he needs to live? And they just looked at me and said, ‘It can’t be approved.’”

Turns out, Thomas said, “They were using the wrong set of guidelines…The qualifying agency that made the determination of whether or not you could use proton therapy was using 15-year-old data to turn people down.”

Due to medical confidentiality, the Veteran’s Administration could not specifically comment on Davis’ case. In a response to questions from the Trice Edney News Wire, VA spokesman David Hodge said the VA is currently researching the status of its proton beam therapy coverage and policies pertaining to it. He did not get back to this reporter with details by deadline as he waited for the information.

Meanwhile, the questions and criticism from Davis and Thomas appear even more relevant given the proximity of Hampton University to people who might need the therapy. According to Thomas, the city of Portsmouth has the highest African-American cancer death rate in the entire state. That includes the city of Petersburg, which leads the nation with Black men dying from prostate cancer. Both Portsmouth and Petersburg are less than an hour from Hampton University.

Thomas describes how Black veterans – often with other illnesses such as diabetes or cardiovascular disease - have to travel lengthy distances to other hospitals in the state for treatments that they did not prefer.

“And less than 10 minutes away was Hampton University Proton Therapy. To me that’s an ungodly unbreakable sin. It almost makes me want to cry from time to time,” he said. “I’ve had veterans, for example, a Marine veteran from North Carolina who served in Vietnam; the man broke down and cried. And that’s why you hear me yelling and screaming about this.”

According to the National Cancer Institute (NCI), a federal government agency, "For African American men, the risk of dying from low-grade  prostate cancer is double that of men of other races."

ZEROCANCER.ORG reports, "One in six Black men will develop prostate cancer in his lifetime. Overall, Black men are 1.7 times more likely to be diagnosed with—and 2.1 times more likely to die from—prostate cancer than white men. Black men are also slightly more likely than white men to be diagnosed with advanced disease."

In a nutshell, the Hampton University Proton Therapy Institute (HUPTI) uses proton therapy, which is a "clinically proven advanced radiation technology," according to its website.

On News.Hampton.U.edu, the procedure is described: "Protons safely and precisely target your cancer while effectively promoting less damage to healthy tissue, reduced side effects and improved quality of life during and after treatment."

The website continues, "Through advocacy, education and state-of-the-art precision medicine, HUPTI has been treating breast, lung, prostate, head and neck, ocular, GI, brain and spine and pediatric cancers since" its inception in 2010.

Despite what appears to be puzzling resistance to proton therapy, even the NCI says the proton beam procedure appears to be just as safe and effective as other cancer radiation.

NCI reports that a study led two years ago by Brian Baumann, M.D., of the Washington University School of Medicine in St. Louis and the University of Pennsylvania, gave no reason for the resistance. According to the NCI report:

“He and his colleagues analyzed data from nearly 1,500 adults with 11 different types of cancer. All participants had received simultaneous chemotherapy plus radiation at the University of Pennsylvania Health System between 2011 and 2016 and had been followed to track side effects and cancer outcomes, including survival. Almost 400 had received proton therapy and the rest received traditional radiation.”

The results:

• “Those who received proton therapy experienced far fewer serious side effects than those who received traditional radiation, the researchers found. Within 90 days of starting treatment, 45 patients (12%) in the proton therapy group and 301 patients (28%) in the traditional radiation group experienced a severe side effect—that is, an effect severe enough to warrant hospitalization.

• “Proton therapy didn’t affect people’s abilities to perform routine activities like housework as much as traditional radiation. Over the course of treatment,  performance status scores were half as likely to decline for patients treated with proton therapy as for those who received traditional radiation.”

• “Proton therapy appeared to work as well as traditional radiation therapy to treat cancer and preserve life. After 3 years, 46% of patients in the proton therapy group and 49% of those in the traditional radiation therapy group were cancer free. Fifty-six percent of people who received proton therapy and 58% of those who received traditional radiation were still alive after 3 years.”

With help from a benefit gala, held by the university, Davis was able to obtain the necessary funds for the therapy. Now, in addition to his regular day job, he now travels around the nation, educating especially Black men about prostate cancer and giving presentations on cancer and proton beam.

“Most men don’t even know what a prostate is,” said Davis, whose father died of prostate cancer. Davis is the father of a 54-year-old son and a 25-year-old grandson, who he also encourages about their health.

Medical experts agree that everyone’s medical condition is unique. Therefore, not all outcomes will be the same.

But, Davis said after the proton beam treatment, he had no sexual dysfunctions.

“It relieves stress and sorrow and somebody’s just playing these games with it,” he said, concluding, “Proton beam from the Hampton University Proton Therapy Institute, I believe it has saved my life. I really do. And it has been an enjoyable time for me to continue to live my life. The cancer is gone. And it happened at an HBCU... That boosted my pride.”