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Ask Dr. Kevin: Clinical Trials are the Foundation for Scientific Innovation

NNPA NEWSWIRE — As you may have heard, my team at Pfizer recently experienced a significant disappointment. Our phase 3 trial for rivipansel, a potential treatment for the debilitating vaso-occlusive crises (VOCs) endured by virtually every person with sickle cell disease (SCD), did not meet its study endpoints. Both professionally and personally, this news was hard to hear, especially knowing that people with SCD have such limited treatment options available to them. However, even though the study didn’t turn out as we had hoped, the good news is that the rivipansel program greatly advanced our understanding of SCD and VOCs, which will be important for future SCD research programs and drug development.

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Dr. Kevin Williams is the Chief Medical Officer (CMO) for Pfizer Rare Disease. In this role, he leads a Medical Affairs organization of approximately 150 medical colleagues around the globe supporting Pfizer’s efforts and portfolio in Rare Disease.

By Dr. Kevin Williams, Chief Medical Officer for Rare Disease at Pfizer

The “Ask Dr. Kevin” series is brought to you by Pfizer Rare Disease in collaboration with the National Newspaper Publishers Association (NNPA) to increase understanding of sickle cell disease.

Dr. Kevin Williams is the Chief Medical Officer for Rare Disease at Pfizer where he leads a Medical Affairs organization of approximately 150 medical colleagues around the globe. He pursued medicine after being inspired by his father’s work as a general practitioner in his hometown of Baton Rouge, Louisiana. Dr. Kevin is passionate about raising awareness and increasing understanding of rare diseases, such as sickle cell disease, in the African American community.

As you may have heard, my team at Pfizer recently experienced a significant disappointment. Our phase 3 trial for rivipansel, a potential treatment for the debilitating vaso-occlusive crises (VOCs) endured by virtually every person with sickle cell disease (SCD), did not meet its study endpoints. Both professionally and personally, this news was hard to hear, especially knowing that people with SCD have such limited treatment options available to them. However, even though the study didn’t turn out as we had hoped, the good news is that the rivipansel program greatly advanced our understanding of SCD and VOCs, which will be important for future SCD research programs and drug development.

As I’ve written about before, SCD is the most common inherited blood disorder, and it disproportionately affects people of African descent[i]. VOCs, one of the most common complications of SCD, are marked by extreme pain resulting from sickle-shaped red blood cells clumping together in the bloodstream[ii]. The standard of care for patients experiencing these pain crises has remained largely unchanged since the first report of SCD in 1910, and is restricted mostly to treating disease symptoms, like the use of opioids for pain management. Just last month, Novartis was granted FDA approval for a treatment to reduce the frequency of VOCs experienced by patients; however, there still stands a greater need for therapies that target the root cause of these painful episodes.

The clinical trial for rivipansel may have come to an end; however, the one thing that working in SCD and collaborating with the NNPA and SCD-focused patient groups over the last several years has taught me is that this community is strong. Their strength inspires me and my team every day and fuels our passion for our work in advancing the scientific research of rare diseases like SCD.

In this article, I’d like to share a little more about the importance of innovation in rare diseases and answer some common questions about the role clinical trials play as the foundation for moving medical innovation forward.

Why are clinical trials important?

Cutting-edge research and clinical trials are key to making an impact for patients and are essential to the development of new treatments. These studies also deepen our understanding of diseases, especially rare diseases, such as SCD, where few advances have been made. For rare diseases in particular, only 5% of diseases have an FDA-approved treatment[iii], so there is a lot of work to be done in this area.

At their core, clinical trials are designed to produce high-quality data that will translate into a better understanding of the treatments that work best for certain diseases and people. Given their crucial role in medical science, clinical trials are highly regulated and conducted using high-quality scientific and ethical standards to ensure the safety of participating patients.

Are there potential challenges associated with clinical trials?

The biggest challenge is that a clinical trial may fail, even after decades of research aimed at uncovering a treatment breakthrough. While no one likes to hear a clinical trial didn’t meet its goals, especially people in need of new treatment options, researchers are unfortunately unable to anticipate the end results of these studies in advance.

However, even though we can’t be sure of the results, it’s still critical for this research to happen to bring new treatment advances to those in need. Did you know that for every approved medicine, there are countless others that don’t pass through the grueling clinical trial and regulatory processes? A recent report found that the likelihood of drugs moving from clinical phase to approval is only 9.6%[iv]. Moreover, even if an investigational therapy is backed by promising data, it can take around 12 years or longer for it to gain approval.

Another challenge can be enrollment of volunteers to participate in clinical trials. Historically, recruitment obstacles have been a barrier in SCD research. However, a poll conducted, as a part of Pfizer and the NNPA’s collaboration, found that a majority of respondents had positive or neutral attitudes toward SCD clinical trials, and furthermore, they indicated a willingness to participate in them if provided the appropriate information. These results are encouraging and suggest people are becoming more inclined to participate in clinical trials for hard-to-treat diseases like SCD.

What have you learned about clinical trials during your time at Pfizer?

Pfizer strives to accelerate the development and delivery of groundbreaking medicines and the dedication, talent and resources that support our clinical trials can’t be captured in a few words. However, as I’ve said earlier, advancing research and conducting clinical trials comes with the unfortunate reality of not always being successful.

The news that our trial for rivipansel didn’t achieve its goals was disappointing, especially for the SCD community who is eagerly awaiting new therapies for VOCs. That said, we are channeling this loss into renewed energy and making it our purpose to learn from it. We are in the process of reviewing the trial data closely to ensure our findings can help inform and shape future SCD programs.

Regardless of the outcomes, I want to stress again that more trials in the rare disease space, particularly for SCD, are desperately needed. I am confident in saying our steadfast commitment to this community will continue, as we work tirelessly to look for new ways to continue advancing care.

About Dr. Kevin Williams

Dr. Kevin Williams is the Chief Medical Officer (CMO) for Pfizer Rare Disease. In this role, he leads a Medical Affairs organization of approximately 150 medical colleagues around the globe supporting Pfizer’s efforts and portfolio in Rare Disease. Dr. Kevin joined Pfizer in January 2004 as a Director of Regional Medical & Research Specialist working in the HIV disease area. After moving into a Team Leader position in July 2005, he served in various leadership roles during his career at Pfizer. Dr. Kevin moved into his current Rare Disease CMO position in May 2016.

Dr. Kevin received his medical degree from the UCLA School of Medicine and is board certified in Internal Medicine. Following a 2-year fellowship in Health Services Research at UCLA and a brief academic career as an Instructor of Medicine at the UCLA School of Medicine, he spent 8 years in private practice caring for HIV-positive patients while maintaining an academic appointment at the UCLA School of Medicine as an Assistant Clinical Professor of Medicine. In addition to his medical degree, Dr. Kevin has a Master’s in Public Health from the UCLA School of Public Health and a Juris Doctorate from Harvard Law School.  

Keep up to date on Pfizer’s Rare Disease efforts by visiting our page here. You can also follow Pfizer on Facebook and Twitter.

[i] Serjeant GR. One hundred years of sickle cell disease. Br J Haematol. 2010;151(5):425-429.

[ii] American Family Physician. “Approach to the Vaso-occlusive Crisis in Adults with Sickle Cell Disease.” https://www.aafp.org/afp/2000/0301/p1349.html.

[iii] Global Genes. “Rare Disease: Facts and Statistics.” https://globalgenes.org/rare-diseases-facts-statistics/

[iv] Biotechnology Innovation Organization (BIO). “Clinical Development Success Rates 2006-2015.” https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf.

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Beloved Actor and Activist Louis Cameron Gossett Jr. Dies at 87

NNPA NEWSWIRE — Louis Gossett Jr., the groundbreaking actor whose career spanned over five decades and who became the first Black actor to win an Academy Award as Best Supporting Actor for his memorable role in “An Officer and a Gentleman,” has died. Gossett, who was born on May 27, 1936, in Brooklyn, N.Y., was 87. Recognized early on for his resilience and nearly unmatched determination, Gossett arrived in Los Angeles in 1967 after a stint on Broadway.
The post Beloved Actor and Activist Louis Cameron Gossett Jr. Dies at 87 first appeared on BlackPressUSA.

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By Stacy M. Brown
NNPA Newswire Senior National Correspondent

@StacyBrownMedia

Louis Gossett Jr., the groundbreaking actor whose career spanned over five decades and who became the first Black actor to win an Academy Award as Best Supporting Actor for his memorable role in “An Officer and a Gentleman,” has died. Gossett, who was born on May 27, 1936, in Brooklyn, N.Y., was 87. Recognized early on for his resilience and nearly unmatched determination, Gossett arrived in Los Angeles in 1967 after a stint on Broadway.

He sometimes spoke of being pulled over by law enforcement en route to Beverly Hills, once being handcuffed to a tree, which he remembered as a jarring introduction to the racial tensions of Hollywood. In his memoir “An Actor and a Gentleman,” Gossett recounted the ordeal, noting the challenges faced by Black artists in the industry. Despite the hurdles, Gossett’s talent shone brightly, earning him acclaim in groundbreaking productions such as “A Raisin in the Sun” alongside Sidney Poitier. His Emmy-winning portrayal of Fiddler in “Roots” solidified his status as a trailblazer, navigating a landscape fraught with racial prejudice.

According to the HistoryMakers, which interviewed him in 2005, Gossett’s journey into the limelight began during his formative years at PS 135 and Mark Twain Junior High School, where he demonstrated early leadership as the student body president. His passion for the arts blossomed when he starred in a “You Can’t Take It With You” production at Abraham Lincoln High School, catching the attention of talent scouts who propelled him onto Broadway’s stage in “Take A Giant Step.” His stellar performance earned him the prestigious Donaldson Award for Best Newcomer to Theatre in 1952. Though initially drawn to sports, Gossett’s towering 6’4” frame and athletic prowess led him to receive a basketball scholarship at New York University. Despite being drafted by the New York Knicks in 1958, Gossett pursued his love for acting, honing his craft at The Actors Studio under the tutelage of luminaries like John Sticks and Peggy Fury.

In 1961, Gossett’s talent caught the eye of Broadway directors, leading to roles in acclaimed productions such as “Raisin in the Sun” and “The Blacks,” alongside legends like James Earl Jones, Cicely Tyson, Roscoe Lee Brown, and Maya Angelou. Transitioning seamlessly to television, Gossett graced small screens with appearances in notable shows like “The Bush Baby” and “Companions in Nightmare.” Gossett’s silver screen breakthrough came with his role in “The Landlord,” paving the way for a prolific filmography that spanned over 50 movies and hundreds of television shows. From “Skin Game” to “Lackawanna Blues,” Gossett captivated audiences with his commanding presence and versatile performances.

However, his portrayal of “Fiddler” in Alex Haley’s groundbreaking miniseries “Roots” earned Gossett critical acclaim, including an Emmy Award. The HistoryMakers noted that his golden touch extended to the big screen, where his role as Sergeant Emil Foley in “An Officer and a Gentleman” earned him an Academy Award for Best Supporting Actor, making him a trailblazer in Hollywood history.

Beyond the glitz and glamour of Hollywood, Gossett was deeply committed to community activism. In 1964, he co-founded a theater group for troubled youth alongside James Earl Jones and Paul Sorvino, setting the stage for his lifelong dedication to mentoring and inspiring the next generation. Gossett’s tireless advocacy for racial equality culminated in the establishment of Eracism, a nonprofit organization dedicated to combating racism both domestically and abroad. Throughout his illustrious career, Gossett remained a beacon of strength and resilience, using his platform to uplift marginalized voices and champion social change. Gossett is survived by his children, Satie and Sharron.

The post Beloved Actor and Activist Louis Cameron Gossett Jr. Dies at 87 first appeared on BlackPressUSA.

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COMMENTARY: D.C. Crime Bill Fails to Address Root Causes of Violence and Incarceration

WASHINGTON INFORMER — The D.C. crime bill and so many others like it are reminiscent of the ‘94 crime bill, which produced new and harsher criminal sentences, helped deploy thousands of police and surveilling methods in Black and brown communities, and incentivized more states to build prisons through a massive infusion of federal funding. While it is not at the root of mass incarceration, it significantly accelerated it, forcing a generation of Black and brown families into a never-ending cycle of state-sanctioned violence and incarceration.
The post COMMENTARY: D.C. Crime Bill Fails to Address Root Causes of Violence and Incarceration first appeared on BlackPressUSA.

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By Kaili Moss and Jillian Burford | Washington Informer

Mayor Bowser has signed the “Secure DC” omnibus bill passed by the D.C. Council last month. But we already know that this bill will be disastrous for all of D.C., especially for Black and brown residents.

While proponents claim that this legislation “will make D.C. residents safer and more secure,” it actually does nothing to address the root of the harm in the first place and instead maintains a cycle of violence, poverty, and broken community ties. The omnibus bill calls for increased surveillance, drug-free zones, and will expand pre-trial detention that will incarcerate people at a significantly higher rate and for an indeterminate amount of time before they are even tried. This bill will roll back decades of nationwide policy reform efforts and initiatives to keep our communities safe and whole, which is completely contradictory to what the “Secure” D.C. bill claims it will do.

What is unfolding in Washington, D.C., is part of a dangerous national trend. We have seen a resurrection of bad crime bills in several jurisdictions across the country — a phenomenon policy experts have named “zombie laws,” which are ineffective, costly, dangerous for communities of color and, most importantly, will not create public safety. Throwing more money into policing while failing to fund preventative measures does not keep us safe.

The D.C. crime bill and so many others like it are reminiscent of the ‘94 crime bill, which produced new and harsher criminal sentences, helped deploy thousands of police and surveilling methods in Black and brown communities, and incentivized more states to build prisons through a massive infusion of federal funding. While it is not at the root of mass incarceration, it significantly accelerated it, forcing a generation of Black and brown families into a never-ending cycle of state-sanctioned violence and incarceration. Thirty years later, despite spending billions each year to enforce these policies with many of these provisions remaining in effect, it has done very little to create long-term preventative solutions. Instead, it placed a permanent moving target on the backs of Black people, and the D.C. crime bill will do the same.

The bill calls for more pretrial detention. When our loved ones are held on pretrial detention, they are held on the presumption of guilt for an indeterminate amount of time before ever seeing a judge, which can destabilize people and their families. According to experts at the Malcolm Weimer Center for Social Policy at Harvard University, just one day in jail can have “devastating consequences.” On any given day, approximately 750,000 people are held in jails across the nation — a number that beats our nation’s capital population by about 100,000. Once detained, people run the risk of losing wages, jobs, housing, mental and health treatments, and time with their families. Studies show that pretrial detention of even a couple of days makes it more likely for that person to be rearrested.

The bill also endangers people by continuing a misguided and dangerous War on Drugs, which will not get drugs off the street, nor will it deter drug use and subsequent substance use disorders (SUDs). Drug policies are a matter of public health and should be treated as such. Many states such as Alabama, Iowa and Wisconsin are treating the current fentanyl crisis as “Crack 2.0,” reintroducing a litany of failed policies that have sent millions to jails and prisons instead of prioritizing harm reduction. Instead, we propose a simple solution: listen to members of the affected communities. Through the Decrim Poverty D.C. Coalition, community members, policy experts and other stakeholders formed a campaign to decriminalize drugs and propose comprehensive legislation to do so.

While there are many concerning provisions within the omnibus bill, car chases pose a direct physical threat to our community members. In July 2023, NBC4 reported that the D.C. Council approved emergency legislation that gave MPD officers the ability to engage in vehicular pursuits with so-called “limited circumstances.” Sgt. Val Barnes, the head of MPD’s carjacking task force, even expressed concern months before the decision, saying, “The department has a pretty strict no-chase policy, and obviously for an urban setting and a major metropolitan city, that’s understandable. If our law enforcement officers themselves are operating with more concern than our elected officials, what does it say about the omnibus bill’s purported intention to keep us safe?

And what does it mean when the risk of bodily harm is posed by the pursuit itself? On Saturday, Feb. 10, an Eckington resident had a near-miss as a stolen car barreled towards her and her dog on the sidewalk with an MPD officer in pursuit. What responsibility does the city hold if this bystander was hit? What does restitution look like? Why are our elected officials pushing for MPD officers to contradict their own policies?

Just a few summers ago during the uprisings of 2020, we saw a shift in public perspectives on policing and led to legislation aimed at limiting police power after the highly-publicized murders of loved ones Breonna Taylor and George Floyd — both victims of War on Drugs policing and the powers gained from the ’94 crime bill. And yet here we are. These measures do not keep us safe and further endanger the health of our communities.  Studies show that communities that focus on harm reduction and improving material conditions have a greater impact on public safety and community health. What’s missing in mainstream conversations about violent crime is the violence that stems from state institutions and structures that perpetuate racial and class inequality. The people of D.C. deserve to feel safe, and that includes feeling safe from the harms enacted by the police.

Kaili Moss is a staff attorney at Advancement Project, a national racial justice and legal organization, and Jillian Burford is a policy organizer at Harriet’s Wildest Dreams.

The post COMMENTARY: D.C. Crime Bill Fails to Address Root Causes of Violence and Incarceration first appeared on BlackPressUSA.

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Mayor, City Council President React to May 31 Closing of Birmingham-Southern College

THE BIRMINGHAM TIMES — “This is a tragic day for the college, our students, our employees, and our alumni, and an outcome so many have worked tirelessly to prevent,” Rev. Keith Thompson, chairman of the BSC Board of Trustees said in an announcement to alumni. “We understand the devastating impact this has on each of you, and we will now direct our efforts toward ensuring the smoothest possible transition for everyone involved.”
The post Mayor, City Council President React to May 31 Closing of Birmingham-Southern College first appeared on BlackPressUSA.

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By Barnett Wright | The Birmingham Times

Birmingham-Southern College will close on May 31, after more than a century as one of the city’s most respected institutions.

“This is a tragic day for the college, our students, our employees, and our alumni, and an outcome so many have worked tirelessly to prevent,” Rev. Keith Thompson, chairman of the BSC Board of Trustees said in an announcement to alumni. “We understand the devastating impact this has on each of you, and we will now direct our efforts toward ensuring the smoothest possible transition for everyone involved.”

There are approximately 700 students enrolled at BSC this semester.

“Word of the decision to close Birmingham Southern College is disappointing and heartbreaking to all of us who recognize it as a stalwart of our community,” Birmingham Mayor Randall Woodfin said in a statement. “I’ve stood alongside members of our City Council to protect this institution and its proud legacy of shaping leaders. It’s frustrating that those values were not shared by lawmakers in Montgomery.”

Birmingham City Council President Darrell O’Quinn said news of the closing was “devastating” on multiple levels.

“This is devastating for the students, faculty members, families and everyone affiliated with this historic institution of higher learning,” he said. “It’s also profoundly distressing for the surrounding community, who will now be living in close proximity to an empty college campus. As we’ve seen with other institutions that have shuttered their doors, we will be entering a difficult chapter following this unfortunate development …   We’re approaching this with resilience and a sense of hope that something positive can eventually come from this troubling chapter.”

The school first started as the merger of Southern University and Birmingham College in 1918.

The announcement comes over a year after BSC officials admitted the institution was $38 million in debt. Looking to the Alabama Legislature for help, BSC did not receive any assistance.

This past legislative session, Sen. Jabo Waggoner sponsored a bill to extend a loan to BSC. However, the bill subsequently died on the floor.

Notable BSC alumni include former New York Times editor-in-chief Howell Raines, former U.S. Sen. Howell Heflin and former Alabama Supreme Court Chief Justice Perry O. Hooper Sr.

This story will be updated.

The post Mayor, City Council President React to May 31 Closing of Birmingham-Southern College first appeared on BlackPressUSA.

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