Finding Treatments and Cures Tailored for You!

Pictured left to right: Mary Ann Gomez-CHLI Executive Director, Jocelyn Ulrich-Sr. Director Scientific & Regulatory Affairs, PhRMA, Dr. Valerie Montgomery-Rice-President and Dean, Morehouse School of Medicine, Congresswoman Ileana Ros Lihtinen (R-FL), Dr. Elena Rios - President, National Hispanic Medical Association, Karen Price-Sr. Director Pfizer, Dr. Jonca Bull-Director Minority Health US Food and Drug Administration, Tashea Holdip-Patient Assistance Pfizer, Maria Firvida-Director, Government Affairs,  AstraZeneca and CHLI Board Member

Pictured left to right: Mary Ann Gomez-CHLI Executive Director, Jocelyn Ulrich-Sr. Director Scientific & Regulatory Affairs, PhRMA, Dr. Valerie Montgomery-Rice-President and Dean, Morehouse School of Medicine, Congresswoman Ileana Ros Lihtinen (R-FL), Dr. Elena Rios – President, National Hispanic Medical Association, Karen Brooks Sr. Director Pfizer, Dr. Jonca Bull-Director Minority Health US Food and Drug Administration, Tashea Holdip-Patient Assistance Pfizer, Maria Firvida-Director, Government Affairs, AstraZeneca.

 

By Atiba Madyun

“Twenty-first century businesses will rely on American science and technology, research and development.  I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time.” President Barack Obama 2015 State of the Union

Personalized medicine is changing the way medicine and treatment therapies are administered.  Unfortunately, minorities or sub-group American populations are not fully benefitting from the changing science, because they are not fully integrated as clinical trial participants.  “Research shows that if patients are asked, they will participate.”  Dr. Valerie Montgomery-Rice, President and Dean of Morehouse School of Medicine said during a Congressional briefing, convened by the Congressional Hispanic Leadership Institute (CHLI) last week on Capitol Hill.

Some attribute a lack of minority participation to the Tuskegee syphilis experiment.  An infamous study conducted from 1932 to 1972.  During that study, the US Public Health Service told black male participants they were treating them, but they were not.  Men died, 40 women contracted the disease and 19 were born with congenital syphilis.

The effect it has had on minorities participating in clinical trials has and will be debated for years.  Nevertheless, forty years later, medical discoveries are opening new pathways to treat serious illnesses like diabetes and cancer, that disproportionately impact communities of color.

Michael Fitzhugh in Negotiating a Place for Race in Age of Personalized Medicine writes, “Fewer than 5 percent of participants in trials registered with ClinicalTrials.gov are non-Caucasian, University of California-Davis, researchers recently found.  In cancer, one of the most heavily researched fields in medicine, the picture is even worse, with fewer than 2 percent of clinical studies focusing on non-Caucasian ethnic or racial groups, the researchers found.[i]

CHLI’s briefing “How Personal is Your Medicine? How to Improve Clinical Trials and Better Latino Health” addressed this and more.  Panelists from a university, advocacy organization, corporation and government offered their insight on present challenges and how to create more inclusion.

“As President of one of three historically black medical schools, one would think that we don’t have diversity issues.  Many would be surprised to see how many unconscious cultural biases exist there.  For instance, an Asian doctor may only have Asians around them.  While on another floor, a doctor from Africa may only have Africans working with them.” Dr. Montgomery-Rice explained,  “Often, at meetings with my peers, I am the only female sitting at the table among medical school Presidents.”

Her description highlights the harsh reality and need for more practitioners and researchers of color in the medical field, but more importantly the need to get them working together and learning from one another.  “We have to start in 9th grade to get students interested in STEM and on track to medical schools. When we are talking about research, we are talking not just about discovery.  We are talking about the real engagement on the street, which is clinical trials.” Dr. Montgomery-Rice said.

PhRMA companies need access to data to provide timely research and process the data.  Yet when looking at past incidents like the Tuskegee study, we note and recognize that there is mistrust, but there also is not enough inclusion, some of it is systemic and some self imposed.

“It is about having more access to data.” Dr. Elena Rios, President of the National Hispanic Medical Associaition said. “When contractors get contracts from PhRMA companies, they should have to have 30% of those working on the trials be members of subgroups and minority communities.  We cannot continue to say and believe that if something works in one community, that it will work in another.”

For many years, terms like health disparities, health inequity, cultural competence, social determinants of health, and language barriers have been used to define inequalities in healthcare access.  Companies have been told they needed more diversity in their workforce and clinical trial participation.  But what do you do when minorities aren’t asked to participate?  What about when practitioners don’t communicate in a trusting way to patients due to lack of cultural competence? Think of the data that is lost because of language barriers and  cultural challenges?  As Dr. Rios said, “access to data is important.”  Everyone today seems to have a cell phone.  What if information can be gathered simply by a patient communicating to researchers through text or email what  symptoms they are incurring.  Isn’t that data useful?

Recognizing that one treatment therapy works better for one group compared to another is a significant achievement.  It is important to recognize that one size does not always fit all.

As Dr. Montgomery-Rice explained, “If you gave three kids standing at a fence trying to watch a baseball game the same sized box to see over a fence.  What if one is short, another of medium height and the third is tall?  The short one may stand on the box and still not be able to see over the fence.  The second may stand and his head make it just to the top.  The tallest might see well over the fence.  This is how we have to look at health equity.  We have to know what they need, so that we can provide them with what they need.”  Dr. Montgomery Rice said.

Pfizer’s Karen Brooks began her comments with a quote from their Chief Medical Officer, Dr. Freda Lewis-Hall.  “If it was an easy problem it would have been solved 20 years ago.  We are trying to solve Star Wars problems with Flintstone solutions.”

So how do we address the changing world recognizing that there are language and cultural barriers?  Are there other barriers?  A clinical trial may be once a week or month.  What about patients who don’t have paid leave?  Will taking off work be an issue?  The reality is that “some participants may go to their doctor once a year.  Participating in a clinical trial is totally different,”  Brooks said.  “Clinical trial participants are our medical heroes. They are the voice to our science!”

To move toward personalized medicine, “companies need access to more big data.” Dr. Rios shared. “There are 50,000 Hispanic doctors in our database.  We have to empower our physicians who mainly take care of Hispanic patients.”

Recognizing that their respective communities can be better served with greater participation in clinical trials, last year, both the National Hispanic Caucus of State Legislators (NHCSL) and the National Black Caucus of State Legislators (NBCSL) passed policy resolutions to address clinical trial participation.[ii] Both resolutions emphasize the need to better engage their communities by increasing awareness of the importance of participating in clinical trials.

This will not happen without greater involvement, participation and trust.  It also requires more people of color pursuing career pathways in research, development and practice.  The science proves we are on the right path to cure some of our worst diseases.  Cures cannot happen without data, research and the best minds to find effective ways to treat diseases and communicate with broader audiences.  This means, as was emphasized by all the panelists, more diversity in the workforce and younger students being exposed to STEM programs.

As the President highlighted to much fanfare in the medical community during his 2015 State of the Union address, “In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable.  So tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information, we need to keep ourselves and our families healthier.  We can do this.”

[i] Negotiating a Place for Race in Age of Personalized Medicine, by Michael Fitzhugh – http://www.bioworld.com/content/negotiating-place-race-age-personalized-medicine-0

[ii] National Black Caucus of State Legislators, Increasing Clinical Trial Participation 15-35, http://www.nbcsl.org/public-policy/resolutions/item/1359-health-and-human-services-resolution-hhs-15-35.html

National Hispanic Caucus of State Legislators, A Resolution to Increase Public Awareness & Education on Participating in Clinical Trials 2014-8, http://www.nhcsl.org/106/resolution/a-resolution-to-increase-public-awareness-&-education-on-participating-in-clinical-trials/

Atiba  Atiba Madyun is the President of The Madyun Group (TMG), a Public Affairs firm based in Washington, D.C. and creator of Cognitive Relevance (CR) and Party Politics (PP). Follow on Twitter @atibamadyun or Like Atiba Madyun on Facebook.

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Is This About Race? Black Leaders Call for Lynch to Be Appointed

Lynch

Why are Republicans in the US Senate holding up the appointment of nominee for Attorney General, Loretta Lynch?  If confirmed, she will become the first African American woman to hold the position of Attorney General and first to hold a cabinet level position in the Obama Administration.

What makes Lynch’s confirmation interesting is that she’s had a stellar career.  Yet her confirmation has been held up longer than any Attorney General in 30 years.   A glaring and stark comparison to her appointment, is that of Defense Secretary Ashton Carter who was nominated on December 5, 2014 and approved unanimously February 1, 2015.

Observers question, is this is about race?  Lynch was nominated by President Barack Obama on November 8, 2014 and confirmed out of committee, 12-8 on February 26, 2015.   Yet, she waits for the full Senate body to confirm her appointment.

The confirmation has gone from a “process of confirmation to a trial by ordeal that has moved from ridiculous to absurd,” Wade Henderson, President and CEO of the Leadership Conference on Civil and Human Rights said yesterday on an hour long press call about Lynch in which he was joined by Congressional members, the head of a civil rights legal defense group and sorority president.

It is difficult to argue the absurdity of the confirmation considering that Carter who is White was nominated after Lynch and confirmed as she waits for appointment.  Adding to the drama is that nothing in the confirmation hearing questioned or challenged her qualifications or her character.

“The CBC is disturbed that this confirmation has taken four months…..the votes are there today to have her confirmed.  If she was put forward for confirmation today, she would be confirmed by tonight,” Congressional Black Caucus Chair, Congressman G.K. Butterfield (NC) said.

So, is this about race or something else?  Senate Majority Leader Mitch McConnell says her confirmation vote will occur after the Senate votes on a human trafficking bill.  While Senators Jeff Sessions (AL), John Cornyn (TX) and Ted Cruz (TX) have said the President’s action on immigration and Lynch’s defense of his actions are why they oppose her appointment.  Either way, her confirmation hearing has now come and gone.  While Secretary Carter has been nominated and confirmed during a shorter timeframe.

“Rather than focus on race, we should ask, what are women and African Americans perceiving when they watch this?  For those who watched a woman who is an African American woman control the room during her confirmation hearing, also saw her move even the opposition party with her story.  When women all over the country see a woman, move toward getting this job and then see it held up despite her qualifications, what does that say to women?”  Sherilynn Ifel, President and Director-Counsel of the NAACP Legal Defense and Educational Fund stated.

Loretta Elizabeth Lynch, born in Greensboro North Carolina is the U.S. Attorney for the Eastern District of New York.  She has been confirmed for the position twice by the Senate, holding the position now twice, first from 1999-2001 and now since 2010.   With leaders around the country calling for the Senate to vote up or down for her appointment, despite her stellar record, there is speculation two Senators from Lynch’s home state may vote against her confirmation.  One saying before the process began, he would not vote for her.

When the vote happens, some on the call said, it could be one of the closest ever for Attorney General.  Some analysts speculate, that Vice President Joe Biden may provide the deciding vote.

Potential Presidential candidate Hillary Rodham Clinton weighed in this week on Twitter, “Congressional trifecta against women today, 1)Blocking a great nominee, 1st African American woman AG, for longer than any other AG in 30 years 2) Playing politics with trafficking victims 3) Threatening women’s health and rights.”

Dr. Paulette C. Walker, National President of Delta Sigma Theta, Inc., for which Lynch is a member said, “Call upon the Senate to confirm.  The Senate needs to do what it is elected to do and confirm Loretta Lynch.  She has committed her life to make the lives of all Americans better.”

If this is about race or even opposition to the President, the Senate’s disparity in confirming the two nominees, may show that control of the Senate is harder than it was in the minority.  The Republican Senate appears more fractured than what we see on the surface.

Is McConnell holding up the nomination because he is having the same issues Congressman John Boehner experienced with Tea Party members in the House of Representatives?  Either way, holding up the nomination of Lynch, a qualified candidate, may further distance and hurt GOP relations not only with important voting communities of African Americans or Hispanics around immigration.  It may also distance itself with women.

Atiba  Atiba Madyun is the President of The Madyun Group (TMG), a Public Affairs firm based in Washington, D.C. and creator of Cognitive Relevance (CR) and Party Politics (PP). Follow @atibamadyun or like Atiba Madyun on Facebook.

Selma & Ferguson Are Now!

selma

By Atiba Madyun

I applaud the DOJ for its findings released this week on Michael Brown’s senseless, tragic killing in Ferguson!

The findings bring to light what we’ve known a long time, Black men and Hispanic men are too often targeted by police.

But there are other systemic issues, like the revenue states and local jurisdictions rely on by issuing fines. Or the length of time for the same type arrests that Blacks are held or detained.

Ferguson shed light on its department, but this has gone on, too long in the US.

What are the next steps to be taken?

President Obama last week in an Immigration Town Hall in Florida said that only 1/3 of registered voters voted in last year’s midterms.  And that much of the gridlock in Washington could be avoided if more people voted.

In light of the historic anniversary tomorrow of Bloody Sunday in Selma, Alabama, it is important that everyone regardless of political affiliation recognize, acknowledge and do their part in elections simply by casting their VOTE!

Let us remember that many men, women and children died so that we have the right to vote.  Rev. Jesse Jackson said shortly after Ferguson, that if 5,000 more people were registered to vote in Ferguson, they could effect the outcome of their mayoral election.  Guess who picks the Chief of Police?  The Mayor!!!

We speak often of the gridlock in Congress.  Well those who marched in Selma did so 5o years ago so that we could all Vote.  In Ferguson and other reaches of the country, we can continue to complain or we can exercise the right to Vote and elect representatives who best serve the interests of the many not the few.  Selma and Ferguson are now!

We the People can change the gridlock and complexion (pun intended) of the Congress and other elected offices around the nation, if we all VOTE!

Atiba Atiba Madyun is the President of The Madyun Group (TMG), a Public Affairs firm based in Washington, D.C. and creator of Cognitive Relevance (CR) and Party Politics (PP). Follow @atibamadyun or like on Facebook Atiba Madyun

An Open Letter Regarding FMLA Reform

FMLA 1

By Laura Newberry-Yokley

Dear Esteemed Legislator:

I want to tell you a story. It’s a good one with a happy ending, but it’s one that requires immediate policy change.

Let me set the scene. I used to be a high powered, emerging leader at a large health care company, who traveled several times a month, worked on nights and weekends, and loved my job.

On August 20, 2013, I went out on a date with my husband. We didn’t make it to the concert, because I collapsed in our friend’s kitchen. I stopped breathing for 30 seconds. Luckily, a little mouth-to-mouth resuscitation and several chest compressions brought me back. I spent the next four months on the couch and visiting specialist physicians of every type trying to determine a diagnosis and then the next six months working part-time with what little energy I had regained.

My company was wonderfully supportive through this time. Don’t get me wrong, they provided excellent medical leave. I was able to eat, pay my medical bills, and keep my household running. I am grateful, very grateful, for their support and for the policies they were complying with.

While I was out on medical leave, though, I got pregnant. I can joke now about being horizontal and getting pregnant. But it wasn’t funny at the time. I was barely sustaining my own life. How was I going to support and grow another life too? Another grateful experience, because I did. And I have a nine-month-old, healthy son to show for it.

I fell through the cracks. My pregnancy was normal – not a disability – but I had the debilitating illness of my own.

You probably understand how medical leave and maternity leave work. To qualify for FMLA, an employee must have worked for the same employer for at least 12 months and clocked at least 1,250 hours of service during the 12 months leading up to FMLA leave. Any organization with 50 or more employees working within a 75-mile radius of the work site must comply with FMLA.

A normal pregnancy is not considered a disability under the Americans with Disabilities Act (ADA). If a woman experiences pregnancy complications that substantially limit a major life activity, she may be considered disabled under the ADA and, therefore, entitled to reasonable accommodation to perform her job.

FMLA and short term disability work well enough if you don’t get sick and pregnant in the same twelve month period like I did. I can argue too that paid maternity leave isn’t provided for everyone or isn’t long enough, but I want to argue that maternity leave should be separated from medical/disability leave. Companies must comply with federal regulation; most are doing what they’re required to by law. But it isn’t enough.

What I didn’t realize about FMLA and short-term disability is that your 12 weeks of FMLA exhausts first and then your short-term disability kicks in. You do not get to decide how your FMLA is to be allocated, like I thought. I thought I would be able to reserve my FMLA leave for my son. Suddenly, it dawned on me, my FMLA was what I was planning on using for maternity leave and it was no longer available.

I had exhausted all available leaves. So, my company and I parted ways – there was no other way forward.

I grew up with the saying, “every mother is a working mother.” And I have had two very different experiences with both of my children. I was a professional working mother with my first and now I am a stay-at-home working mother this time. In the nine months since giving birth to my son, I’ve incorporated self-care into my day by walking and writing. In July, I started my own company, where I examine with my clients the self-exploration of leadership and cultural and linguistic aspects of global business. Let’s face it. I’m doing what I love – being a more-present mom and consulting on the things I am truly passionate about (diversity and inclusion; social entrepreneurship; leadership). So this story ends well.

I also grew up knowing that women’s bodies are immensely powerful beyond measure. I know of my own body’s power – I was able to heal, grow and birth two children, and rally after experiencing long-term illness. So that story ends well, too.

Our policies must support our powerful bodies to their fullest extent, even in illness. Please change the laws so that:

  • Maternity leave reclassified so it does not reside in Family Medical Leave Act.
  • If one gets pregnant when they are sick, they should not be penalized.
  • All moms require paid maternity leave. No current law requires companies to provide paid maternity leave – most comply with the Pregnancy Discrimination Act (PDA) and the Family and Medical Leave Act (FMLA). Yet 11% of Americans employed by private industry have access to some form of paid family leave.

Thanks for reading. I know I’m quite possibly an exception to the rule, but you’ve got to figure, I’m probably not the only one who has experienced this.

Sincerely,

laura

Laura - Headshot 3 Laura Newberry-Yokley is a cultural innovation consultant and holistic leadership coach with Sonrisa Products, LLC.  She has spent her career researching women around the world.  She works to close health disparities for vulnerable populations and teaches Self-care to her clients.

Logo Follow Laura on Twitter @sonrisaproducts