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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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#NNPA BlackPress

COMMENTARY: The National Protest Must Be Accompanied with Our Votes

Just as Trump is gathering election data like having the FBI take all the election data in Georgia from the 2020 election, so must we organize in preparation for the coming primary season to have the right people on ballots in each Republican district, so that we can regain control of the House of Representatives and by doing so, restore the separation of powers and balance that our democracy is being deprived of.

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Dr. John E. Warren Publisher, San Diego Voice & Viewpoint
Dr. John E. Warren, Publisher San Diego Voice & Viewpoint Newspaper. File photo..

By  Dr. John E. Warren, Publisher San Diego Voice & Viewpoint Newspaper

As thousands of Americans march every week in cities across this great nation, it must be remembered that the protest without the vote is of no concern to Donald Trump and his administration.

In every city, there is a personal connection to the U.S. Congress. In too many cases, the member of Congress representing the people of that city and the congressional district in which it sits, is a Republican. It is the Republicans who are giving silent support to the destructive actions of those persons like the U.S. Attorney General, the Director of Homeland Security, and the National Intelligence Director, who are carrying out the revenge campaign of the President rather than upholding the oath of office each of them took “to Defend The Constitution of the United States.”

Just as Trump is gathering election data like having the FBI take all the election data in Georgia from the 2020 election, so must we organize in preparation for the coming primary season to have the right people on ballots in each Republican district, so that we can regain control of the House of Representatives and by doing so, restore the separation of powers and balance that our democracy is being deprived of.

In California, the primary comes in June 2026. The congressional races must be a priority just as much as the local election of people has been so important in keeping ICE from acquiring facilities to build more prisons around the country.

“We the People” are winning this battle, even though it might not look like it. Each of us must get involved now, right where we are.

In this Black History month, it is important to remember that all we have accomplished in this nation has been “in spite of” and not “because of.” Frederick Douglas said, “Power concedes nothing without a struggle.”

Today, the struggle is to maintain our very institutions and history. Our strength in this struggle rests in our “collectiveness.” Our newspapers and journalists are at the greatest risk. We must not personally add to the attack by ignoring those who have been our very foundation, our Black press.

Are you spending your dollars this Black History Month with those who salute and honor contributions by supporting those who tell our stories? Remember that silence is the same as consent and support for the opposition. Where do you stand and where will your dollars go?

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Why Black Parents Should Consider Montessori

BLACKPRESSUSA NEWSWIRE — I have found that there are some educational approaches that consistently provide a safer, more enriching, and more affirmative environment for Black children. The Montessori method, developed by Italian physician Maria Montessori and introduced to the U.S. in the early 20th century, is one such approach.

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By Laura Turner-Essel, PhD

As a mother of four children, I’ve done A LOT of school shopping. I don’t mean the autumn ritual of purchasing school supplies. I mean shopping for schools – pouring over promotional materials, combing through websites, asking friends and community members for referrals to their favorite schools, attending open houses and orientations, comparing curriculums and educational philosophies, meeting teachers and principals, and students who all claim that their school is the best.

But keep in mind – I’m not just a mom of four children. I’m a mom of four Black children, and I’m also a psychologist who is very interested in protecting my little ones from the traumatic experience that school can too often become.

For Black children in the United States, school can sometimes feel more like a prison than an educational institution. Research shows that Black students experience school as more hostile and demoralizing than other students do, that they are disciplined more frequently and more harshly for typical childhood offenses (such as running in the halls or chewing gum in class), that they are often labeled as deviant or viewed as deficient more quickly than other children, that teachers have lower academic expectations of Black students (which, in turn, lowers those students’ expectations of themselves), and that Black parents feel less respected and less engaged by their children’s teachers and school administrators. Perhaps these are some of the underlying reasons that Black students tend to underperform in most schools across the country.

The truth is that schools are more than academic institutions. They are places where children go to gain a sense of who they are, how they relate to others, and where they fit into the world. The best schools are places that answer these questions positively – ‘you are a valuable human being, you are a person who will grow up to contribute great things to your community, and you belong here, with us, exploring the world and learning how to use your gifts.’ Unfortunately, Black children looking for answers to these universal questions of childhood will often hit a brick wall once they walk into the classroom. If the curriculum does not reflect their cultural experiences, the teachers don’t appear to value them, and they spend most of their time being shamed into compliance rather than guided towards their highest potential, well…what can we really expect? How are they supposed to master basic academic skills if their spirits have been crushed?

Here’s the good news. In my years of school shopping, and in the research of Black education specialists such as Jawanza Kunjufu and Amos Wilson, I have found that there are some educational approaches that consistently provide a safer, more enriching, and more affirmative environment for Black children. The Montessori method, developed by Italian physician Maria Montessori and introduced to the U.S. in the early 20th century, is one such approach.

The key feature of Montessori schooling is that children decide (for the most part) what they want to do each day. Led by their own interests and skill levels, children in a Montessori classroom move around freely and work independently or with others on tasks of their own

choosing. The classroom is intentionally stocked with materials tailored to the developmental needs of children, including the need to learn through different senses (sight, touch/texture, movement, etc.). The teacher in a Montessori classroom is less like a boss and more like a caring guide who works with each child individually, demonstrating various activities and then giving them space to try it on their own. The idea is that over time, students learn to master even the toughest tasks and concepts, and they feel an intense sense of pride and accomplishment because they did it by themselves, without pressure or pushing.

I think that this aspect of the Montessori method is good for all kids. Do you remember the feeling of having your creativity or motivation crushed by being told exactly what to do, when to do it, how to do it, and why? The truth is that when presented with a new challenge and then given space, children actually accomplish a lot! They are born with a natural desire to learn. It is that spirit of curiosity, sense of wonder, and excitement to explore that Montessori helps to keep alive in a child. But that’s not the only reason that I think Black parents need to consider Montessori.

Fostering a love of learning is great. But more importantly, I think that Montessori students excel at learning to love. It begins with Montessori’s acknowledgement that all children are precious because childhood is a precious time. In many school systems, Black children are treated like miniature adults (at best) or miniature criminals (at worst), and are subjected to stressful situations that no kids are equipped to handle – expectations to be still and silent for long periods, competitive and high-stakes testing, and punitive classroom discipline. It’s easy to get the sense that rather than being prepared for college or careers, our children are being prepared to fail. Couple this with the aforementioned bias against Black children that seems to run rampant within the U.S. school system, and you end up with children who feel burned out and bitter about school by the time they hit 3rd grade.

In my experience, Montessori does a better job of protecting the space that is childhood – and all the joy of discovery and learning that should come along with that. Without the requirement that students “sit down and shut up,” behavioral issues in Montessori classrooms tend to be non-existent (or at least, the Montessori method doesn’t harp on them; children are gently redirected rather than shamed in front of the class). Montessori students don’t learn for the sake of tests; they demonstrate what they’ve learned by sharing with their teacher or classmates how they solve real-world problems using the skills they’ve gained through reading, math, or science activities. And by allowing children a choice of what to focus on throughout the day, Montessori teachers demonstrate that they honor and trust children’s natural intelligence. The individualized, careful attention they provide indicates to children that they are each seen, heard, and valued for who they are, and who they might become. Now that’s love (and good education).

As a parent, I’ve come to realize that many schools offer high-quality academics. Montessori is no different. Students in Montessori schools gain exposure to advanced concepts and the materials to work with these concepts hands-on. Across the nation, Montessori schools emphasize early literacy development, an especially important indicator of life success for young Black boys and men. Montessori students are provided with the opportunity to be

successful every day, and the chance to develop a sense of competence and self-worth based on completing tasks at their own pace.

But I have also learned that the important questions to ask when school shopping are often not about academics at all. I now ask, ‘Will my children be treated kindly? Will they be listened to? Protected from bias and bullying? Will they feel safe? Will this precious time in their lives be honored as a space for growth, development, awe, and excitement? Will they get to see people like them included in the curriculum? Will they be seen as valuable even if they don’t always ‘measure up’ to other kids on a task? Will they get extra support if they need it? Will the school include me in major decisions? Will the school leaders help to make sure that my children reach their fullest potential? Will the teacher care about my children almost as much as I do?’

Consistently, it’s been the Montessori schools that have answered with a loud, resounding ‘Yes!’ That is why my children ended up in Montessori schools, and I couldn’t be happier with that decision. If you’re a parent like me, shopping for schools with the same questions in mind, I’d urge you to consider Montessori education as a viable option for your precious little ones. Today more than ever, getting it right for our children is priceless.

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LIVE from the NMA Convention Raheem DeVaughn Says The Time Is Now: Let’s End HIV in Our Communities #2

Set against the backdrop of the NMA conference, Executive Officers from the National Medical Association, Grammy Award Winning Artist and Advocate Raheem DeVaughn, and Gilead Sciences experts, are holding today an important conversation on HIV prevention and health equity. Black women continue to be disproportionately impacted by HIV despite advances in prevention options. Today’s event […]

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Set against the backdrop of the NMA conference, Executive Officers from the National Medical Association, Grammy Award Winning Artist and Advocate Raheem DeVaughn, and Gilead Sciences experts, are holding today an important conversation on HIV prevention and health equity.

Black women continue to be disproportionately impacted by HIV despite advances in prevention options. Today’s event is designed to uplift voices, explore barriers to access, and increase awareness and key updates about PrEP, a proven prevention method that remains underutilized among Black women. This timely gathering will feature voices from across health, media, and advocacy as we break stigma and center equity in HIV prevention.

Additional stats and information to know:

Black women continue to be disproportionately affected by HIV, with Black women representing more than 50% of new HIV diagnoses among women in the U.S. in 2022, despite comprising just 13% of women in the U.S.

Women made up only 8% of PrEP users despite representing 19% of all new HIV diagnoses in 2022.

● Gilead Sciences is increasing awareness and addressing stigma by encouraging regular HIV testing and having judgment-free conversations with your healthcare provider about prevention options, including oral PrEP and long-acting injectable PrEP options.

● PrEP is an HIV prevention medication that has been available since 2012.

● Only 1 in 3 people in the U.S. who could benefit from PrEP were prescribed a form of PrEP in 2022.

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