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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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Brittney Griner Sentenced to More than 9 years in Russian Prison

NNPA NEWSWIRE — The lawyers of WNBA star Brittney Griner, Maria Blagovolina and Alexander Boykov, said in a written statement following the verdict announcement that the court ignored all the evidence they presented and that they will appeal the decision. “We are very disappointed by the verdict. As legal professionals, we believe that the court should be fair to everyone regardless of nationality,” Attorneys Maria Blagovolina and Alexander Boykov said in a statement.

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By Stacy M. Brown, NNPA Newswire Senior National Correspondent
@StacyBrownMedia

WNBA Superstar Brittney Griner has been sentenced to more than 9 years in a Russian prison following her conviction on drug charges.

Her lawyers called the verdict a disappointment and vowed to appeal.

The lawyers of WNBA star Brittney Griner, Maria Blagovolina and Alexander Boykov, said in a written statement following the verdict announcement that the court ignored all the evidence they presented and that they will appeal the decision.

“We are very disappointed by the verdict. As legal professionals, we believe that the court should be fair to everyone regardless of nationality,” Attorneys Maria Blagovolina and Alexander Boykov said in a statement.

“The court completely ignored all the evidence of the defense, and most importantly, the guilty plea. This contradicts the existing legal practice.

“Taking into account the amount of the substance (not to mention the defects of the expertise) and the plea, the verdict is absolutely unreasonable. We will certainly file an appeal,” they added.

Russian officials contended that Griner committed the crime on purpose. They also levied a fine totaling about $16,400 American dollars on the basketball star.

Authorities arrested Griner on Feb. 17 at an airport in Moscow after finding less than a gram of cannabis oil in her luggage.

She has been detained since then.

Recently, American officials revealed that the Biden-Harris administration had offered notorious arms dealer Viktor Bout in exchange for the release of Griner and Paul Whelan.

“Today, American citizen Brittney Griner received a prison sentence that is one more reminder of what the world already knew: Russia is wrongfully detaining Brittney,” President Biden said.

“It’s unacceptable, and I call on Russia to release her immediately so she can be with her wife, loved ones, friends, and teammates. My administration will continue to work tirelessly and pursue every possible avenue to bring Brittney and Paul Whelan home safely as soon as possible.”

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Report: Human Rights Violations in Prisons Throughout Southern United States Cause Disparate and Lasting Harm in Black Communities  

NNPA NEWSWIRE — “The U.S. has long failed to live up to its international human rights treaty obligations on eliminating racial discrimination, perhaps more so in the area of mass incarceration and prison conditions than in any other context,” said Lisa Borden, Senior Policy Counsel, International Advocacy at the Southern Poverty Law Center. 

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NNPA Newswire

NEW YORK – The Southern Prisons Coalition, a group of civil and human rights organizations, submitted a new report to the United Nations Committee on the Elimination of All Forms of Racial Discrimination on the devastating consequences of incarceration on Black people throughout the southern United States.

With the long-term goal of eliminating all forms of racial discrimination in the criminal legal system, including the carceral system, the report describes the widespread, disparate harms resulting from the arrests, harsh prison sentences, and incarceration on Black communities.

The report also cites the devastating impacts of solitary confinement, prison labor, the school to prison pipeline, and incarceration of parents on Black families.

On August 8, 2022, the UN will review the United States’ compliance with the International Convention on the Elimination of All Forms of Racial Discrimination for the first time since 2014.

Among the ongoing stark racial disparities throughout prisons in the southern United States, Black people are five times more likely to be incarcerated in state prisons.

In states like Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, and Texas, where Black communities comprise 38% of the total population, Black individuals account for as much as 67% of the total incarcerated population.

While incarcerated, Black people are more than eight times more likely to be placed in solitary confinement, and they are 10 times more likely to be held there for exceedingly long periods of time.

By submitting the report to the United Nations, the Southern Prisons Coalition hopes to solicit concrete recommendations from the UN Committee as well as commitments from the United States delegation about their plans to address systemic issues in the United States prison system, particularly in the South.

According to the report, several states in the United States have also failed to meet several of the UN’s Standard Minimum Rules for the treatment of incarcerated people, including:

  • Work should help to prepare incarcerated people for their release from prison, including life and job skills;
  • Safety measures and labor protections for incarcerated workers should be the same as those that cover workers who are not incarcerated;
  • Incarcerated workers should receive equitable pay, be able to send money home to their families, and have a portion of their wages set aside to be given to them upon release.

“The U.S. has long failed to live up to its international human rights treaty obligations on eliminating racial discrimination, perhaps more so in the area of mass incarceration and prison conditions than in any other context,” said Lisa Borden, Senior Policy Counsel, International Advocacy at the Southern Poverty Law Center.

“We hope the Committee will help to shine a light on these very dark truths and prompt the U.S. to take its obligation to make significant improvements more seriously.”

“The abuses of forced labor are inextricably tied to racial discrimination in our nation,” said Jamila Johnson, Deputy Director at the Promise of Justice Initiative.

“In Louisiana, for instance, people are still sent into the fields to labor by hand in dangerously high heat indexes, for little to no compensation, and with brutal enforcement reminiscent of slavery and the era of ‘convict leasing’.”

“This report reveals the suffering of Black people in southern U.S. prisons, whose stories of marginalization and discrimination echo the racial subjugation of slavery and convict leasing during our country’s most shameful past,” said Antonio L. Ingram II, Assistant Counsel at the Legal Defense Fund.

“Despite widespread knowledge of the longstanding racial inequalities in the criminal legal and carceral systems, the United States continues to allow egregious human rights violations to persist for Black incarcerated people in violation of international law. This report serves as a sobering reminder of how far we need to go.”

Read the full report here.

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Celebrate your birthday with 10 free items

NNPA NEWSWIRE — Is your birthday coming up, and you’re not sure how to celebrate? Beat the summer heat by grabbing free ice cream at Cold Stone Creamery, or a daiquiri at WhoDaq Daquiris “The Daiquiri Shoppe.” Not in the mood for sweets? Head over to Jersey Mike’s or McDonald’s. Check out the rest of these Top 10 places giving out free items on your special day.

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By Angelina Liu, Entertainment Editor of The Trendsetter / Texas Metro News

Is your birthday coming up, and you’re not sure how to celebrate? Beat the summer heat by grabbing free ice cream at Cold Stone Creamery, or a daiquiri at WhoDaq Daquiris “The Daiquiri Shoppe.” Not in the mood for sweets? Head over to Jersey Mike’s or McDonald’s. Check out the rest of these Top 10 places giving out free items on your special day.

1. Chocolate Secrets

At Chocolate Secrets, located at 3926 Oak Lawn Ave, Dallas, TX 75219, you can celebrate your birthday by getting one free piece of candy under their candy cases.

2. WhoDaq Daquiris “The Daiquiri Shoppe”

Head to WhoDaq Daquiris “The Daiquiri Shoppe”, located at 684 W Pioneer Pkwy Suite 100, Grand Prairie, Texas 75051, to claim a free small personal daiquiri on your birthday. Quench your thirst with signature flavors such as “Strawberry Shortcake” or “Bahama Mama.”

3. Sephora

Sign up for a free, Beauty Insider account and receive your choice of 250 bonus points, Laura Mercier, Amika or Tatcha sets on your birthday. The choice of powders, lipsticks and skincare is bound to make you look fabulous for your special day.

4. Starbucks

Need a quick pick-me-up on your birthday? Starbucks has it covered! Join the Starbucks Rewards Program seven days prior to your birthday and make one purchase. Starbucks will then email you a coupon for a free food or beverage item two days before your birthday. The birthday reward qualifies for anything on the menu, including any size handcrafted drink or food item.

5. Jersey Mike’s

In the mood for a sub? Head over to Jersey Mike’s and receive a free sub and drink. Make sure to sign up for the Jersey Mike’s Subs Email Club prior to your birthday to receive this reward. Nothing tastes quite like melted cheese and meat in between a toasted baguette, along with an icy cold drink.

6. The Cheesecake Factory

Celebrating with friends? Tell your server it’s your birthday and receive a free treat as well as a song. It may be mildly embarrassing, but hey, it’s free!

7. Culver’s

Need something cold and sweet to beat the Texas heat? Head to Culver’s for a free sundae when you sign up for their rewards program. The sweet creaminess will surely not disappoint.

8. IHOP

Want to indulge in a sweet breakfast before birthday festivities? Join the International Bank of Pancakes rewards program to receive a free stack of pancakes on your birthday. Pair your pancakes with a choice of chocolate chips, syrup, fresh fruit or a dollop of whipped cream.

9. McDonald’s

Need a snack before embarking on your next birthday adventure? Download the McDonald’s app and join MyMcDonald’s Rewards to receive free large fries. Mmm, the taste and smell of fresh, perfectly salted french fries.

10. Smoothie King

Want to celebrate your birthday with a healthier option? Enjoy a birthday smoothie at Smoothie King. Download the Smoothie King app to receive this offer.

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