Clinical Ambassador-Blog | brokering trust. impacting disparities.

Time 2021-11-19 19:13:52

Web Name: Clinical Ambassador-Blog | brokering trust. impacting disparities.

WebSite: http://clinicalambassador.wordpress.com

ID:239491

Keywords:

Blog,Ambassador,Clinical,brokering,disparities,impacting,trust,

Description:

keywords:
description:brokering trust. impacting disparities.
About Us Clinical Ambassador-Blog brokering trust. impacting disparities. Where Access Meets Accountability: Or, Fame asAnesthesia February 14, 2012Filed under: Where Are We Now Clinical Ambassador @ 11:15 am
Will Whitney Houstons death serve any useful purpose? More to the point, to what extent do we (yes, you) play a role in ensuring that her passing was not in vain?

The beat goes on. The list of minority celebrities gone too soon is getting painfully long. This should underscore the harsh reality that even when socioeconomic status is controlled for, minorities still suffer disproportionate disease burden. For all their access, something more powerful is getting in the way.

Mourning the passing of Whitney Houston, I am overcome with questions about what it would have taken to change this course of events. Was it inevitable? Should her disease of addiction not have been treated as a mental health issue? Perhaps more stress on stressunderstanding the ways in which stress takes its toll on minority healthwould offer actionable insights. In Whitneys case, she had everything going for her, but also had the means for access to a bigger self-destructive arsenal. The decisions we all make concerning our health behaviors make it a public health issue. Will this tragedy serve any useful purpose at all, as a cautionary tale to high risk populations?

How did her sense of empowerment get lost? As with anyone, the buck had to stop at her inherent desire for a different outcome. In my view, empowerment has to equate with a sense of entitlement. I am worthy of better health and better quality of life, therefore I will do all in my power to pursue and preserve it. (Think about all of the actions we take on a daily basisbig and small then remove that sense of entitlement from the equation.)

Of course, entitlement has its dark side as well. It can cause people to believe that they are exceptions to the rules the rest of humanity has to abide by and operate within. And when coupled with extraordinary talent, fame and wealth, entitlement can apparently insulate you from reality in very detrimental ways.

The tally of senseless, avoidable deaths rages on. This needless loss kicks me in the gut on a personal level. But this tragedy is also a public health issue. We have so much work to do, starting with discussing it in a big-picture way in communities of color. We need more innovative research dedicated to untangling these disparities, and then the collective sense of entitlement to know that we can all make a difference. In thinking about how much was lost in her passing, I hope Whitneys public legacy serves some useful purpose that transcends her musical achievements.

Leave a Comment
Henrietta Lacks and HeLa cells: Implications in ClinicalResearch October 20, 2011Filed under: Where Have We Been clinicalminority @ 9:44 pm
Tags: bioethics, clinical research, Henrietta Lacks, medical apartheid, minority, patient recruitment, rebecca skloot

Category    Where Have We Been

Henrietta Lacks circa 1945

For those of you who have experience with in vitro (cellular based) research, you are very likely familiar with the first immortal cell line called HeLa cells. The immortality of these cells, or ability of the cell line to continue be cultured and grown over and over again without dying, has been the cornerstone of research in multiple disciplines, but particularly in oncology (cancer biology) and vaccine research. Understanding how these cancer cells are able to stay alive and are able to replicate has been a pivotal query of scientific discovery for the last sixty years. For example, HeLa cells, a cell line that was derived from the cervical tumor cells of Henrietta Lacks, have been utilized to understand the disease process of Human Papilloma Virus (HPV) and subsequently lead to the development of a HPV vaccine which holds the promise of reducing young womens risk to cervical cancers. However, the contribution of HeLA cells to research and development did not come without the cost of bioethical concerns.

Much of these issues are tackled in the comprehensive narrative by Rebecca Skloot entitled The Immortal Life of Henrietta Lacks. Skloots book brings a biographical view to the life of Henrietta Lacks, including how the cells were originally harvested from this poor Black woman and introduced to the scientific community without her or her familys permission or notification. In addition, the volume explores the past and present impact that this significant medical discovery has had on science, but also on past and present generations of the Lacks family. Skloots research also reminds us of some common bioethical issues in biomedical research that still plague the African-American community. The bioethical issues seen in the case of Lacks (sometimes misidentified as Helen Lane in the literature) during the middle of the 20^th century are not new and include themes such as mistrust of physicians, lack of informed consent, and the ethics of ownership and compensation in biomedical research.

As discussed in a previous posting, we identified Johns Hopkins Hospital (JHH) as one of the first large institutional facilities that provided both care for the African-American community with a colored ward and served as a research training ground for emerging physicians. Johns Hopkins also serves as the backdrop to this story. With the founding of the hospital at the end of the 19^th century, it quickly gained a reputation within the African-American community where black people went to die, instead of being healed. This is in direct contradiction to the mission outlined by the hospitals founder, Johns Hopkins, who wanted to insure that the indigent population of Baltimore, especially poor black children, had access to medical care they ordinarily could not afford. However, the community justifiably believed that the quality of the care in the colored ward was inferior to the main hospital and that the patients were treated as medical experiments and exhibits for physician training. This was further exacerbated by the idea of night doctors where physicians played a role in procuring black cadavers from the surrounding community either by allowing patients to die, facilitating grave robbing or worse, participation in schemes to snatch people from the streets for research purposes. In the case of Henrietta Lacks, when treatments began for her advanced stage cervical cancer, she was given standard of care radium treatment, a ghastly treatment which while known for its ability to kill cancer cells, also was known to have a poor safety profile and Henrietta suffered excruciating pain until her untimely death at the age of 31. David Day Lacks, Henriettas husband, was distraught following his wifes death, as he already held significant mistrust for the doctors at Johns Hopkins. He and his family members knew of the history of JHH for human experimentation and body snatching, so the questionable treatment of Henriettas cancer without consultation with the family was not unexpected. In addition, the subsequent revelation that the scientific bounty derived from HeLa cells stemmed from an unauthorized biopsy by Henriettas physician, Dr. George Gey, was no surprise. Unfortunately, this manner of protocol (or lack thereof) was consistent with the Lacks familys view of perceived unethical, if not deadly, practices at JHH. The history of these events still plagues the reputation of JHH in the African-American community and provides validity to feelings of mistrusts for medical treatment at JHH and at similar types of facilities.

According to the ICH Guidance for Industry on Good Clinical Practice, Informed Consent is defined as, A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Although this guidance was fully adopted in 1996, the ICH guidance represents the amalgamation of codes, doctrines and decrees from the international community on minimum requirements for biomedical research, since the Nuremburg Code was ratified in 1947. As Dr. Gey was engaged in oncology research before he treated Henrietta, it was commonly understood that he would take a biopsy sample of both the tumor and surrounding health tissue for comparison. What was uncommon in the practice was notification to patients or their families of the biopsy process, including notification that the samples had been taken and how the biological material would be used. Henrietta and her family had no idea that her cells had been biopsied and were being studied in culture. It was only made clear through a chance meeting with a family member, where a researcher who had used HeLa cells made the correlation. Even worse, other investigators, such as Dr. Susan Hsu made attempts to take additional biological samples from the Lacks family under false pretenses. The family was told that they were being screened as a preventative measure to see if they shared the deadly cancer with Henrietta. In reality, Dr. Hsu was looking for surrogate markers in the family members that would help explain the immortality of the HeLa cell line. These are clear examples where the pursuit of science overshadowed the use of basic bioethical considerations and violated individual rights to be informed. These violations are particularly egregious, as they occurred after the ratification of the Nuremburg Code. Given this period of time in American history, these unethical practices were overlooked or even justified in the minds of those who participated in institutional racism and the reinforcement of second-class status of African-Americans during this time.

Finally, because the introduction of the HeLa immortalized cell line was one of the most significant scientific discoveries of that time (and of all time), Geys lab was inundated with requests to share the cells. As the potential for replicating cells in culture without them dying or reaching an expansion limit, the implications and use of these cells were infinite. Their resulting commercialization was not only necessary to meet the global demand for the cells, but also seen as an appropriate way to support research and innovation in biomedical research. Ironically, Tuskegee University played an early role in the commercial process, as they served as a HeLa factory for supplying cells to researchers and laboratories globally. It was not long before the demands exceeded their capacity and vast commercialization was picked up by a startup company called Microbiological Associates. With customers such as government agencies (i.e. National Institutes of Health), universities and global researchers, soon Microbiological (now Invitrogen) was selling thousands of lots of HeLa cells around the world. This served as the impetus for the creation of a multi-billion dollar industry exchanging biological supplies. Although difficult to quantify the total revenue generated from HeLa cells through the years, it is estimated to be in the hundreds of millions of dollars. Even today, genetically modified lots are being sold for as much as $10,000 USD.

The HeLa cell line has gone on to be sold by other biological supply companies, but in itself raises several questions, many of which have been appealed up to the Supreme Court Level. Who owns tissues/samples after they are have been harvested from the body? Can scientific discoveries derived from biological samples be patented and commercialized? Are donors, whether voluntary or involuntary, due compensation for discoveries made from their biological specimen? Although many of these questions have been adjudicated in courts, mostly in the favor of scientists and organizations, unresolved accounting still remains regarding the impact on the affected families and the responsibility of the scientific community. Incredibly, the Lacks family was only formally notified of the commercialization of her cells in 1975, some twenty-four years after her death. Although it is clear that the excision of the tumor cells from Henrietta Lacks cervix served as the origin of the parental line of HeLa cells, the Lacks family themselves have received little to no compensation for the contribution.

Although it has been more than sixty years since Henrietta Lacks created this scientific legacy, the impact that she has had on science has been indelible. Significant credit should be given to Skloot for investigative reporting efforts in bringing forth this important story. Unfortunately, it highlights another dark chapter in American history. We must hold fast to the highest ethical considerations, never again allowing the pursuit of science and those in vulnerable positions, i.e. illiterate, lower socioeconomic status, or poor to be exploited or taken advantage of. Empowered with the knowledge of our past, patient protections are now enforced by law, and steps have been taken to avoid similar situations and ensure that patients are treated with respect and as a full, informed, partner in the process.

 

Leave a Comment
Where have we been: Part 3: “BadBlood” August 16, 2011Filed under: Where Have We Been clinicalminority @ 10:41 pm
Tags: bad blood, bioethics, clinical research, iatrophobia, minority, patient recruitment, Tuskegee syphilis

 Category    Where Have We Been

In previous posts, we have discussed the continued pervasive fear of doctors or Iatrophobia in the black community, particularly in the context of their reduced participation in clinical trials. We have highlighted the impact of unethical experimental research during slavery and the antebellum period in the US. In addition, due to the second-class stature of blacks at the turn of the 20^th century, coupled with the rise of large community hospitals, black cadavers were disproportionately training models—their bodies used for medical exploration purposes. However, most would agree that the events associated with the Tuskegee Syphilis experiment, supported by the US Public Health Service, likely carved the deepest impact in the black communitys collective psyche, almost ensuring reticence to participate in clinical trials. Simply performing an internet search for Tuskegee Syphilis provides extensive background from additional resources on the topic. They include the National Archives, Centers for Disease Control, Wikipedia, YouTube and scholarly research from universities such as University of Virginia. In addition, there are at least two in-depth narratives in the public domain that document the impact of the Tuskegee Syphilis experiment. Author James H. Jones, for example, a historian from the University of Houston, penned the definitive accounting of the experiment in Bad Blood: The Tuskegee Syphilis Experiment. In addition, Fred D. Gray, one of the lawyers who represented the participants in a class-action lawsuit against the US government, wrote, The Tuskegee Syphilis Study, a more personal account written from the participants perspective. Both provide insightful perspective

For four decades, from 1932 to 1972, approximately 600 black sharecroppers in rural Macon County, Alabama participated in an US Public Health Service (PHS) experiment entitled, Untreated Syphilis in the Male Negro. What was intended to be a six-month interventional study evolved into an unethical long-term observational study. Patients were denied standard of care treatment for the duration of their participation, including access to penicillin which was introduced as a cure for syphilis in the 1940s. To gain scientific understanding of the impact of untreated syphilis on the central nervous system, patients were hoodwinked into believing that evasive spinal tap procedures were in fact special treatments for their disease state. In return, the subjects were compensated by regular medical visits, free food, and burial insurance provided to their families. Although periodic updates from the study were published in medical journals through the years, the experiment did not receive public attention until an expose released by the Associated Press in 1972 highlighted the atrocity. A national outcry led to an agreement by the Department of Health and Scientific Affairs (the precursor to the Department of Health and Human Services) to end the study in October of the same year. The fallout from the experiment included pivotal changes to the way clinical research is conducted, including the advent of patient informed consent and the creation of the Institutional Review Board to oversee the conduct of studies and the mitigation of risk for participants.

Despite the stringent regulations currently in place, mistrust for the government and the medical establishment amongst blacks took hold in both the facts and the myths surrounding the Tuskegee Experiment. When the Tuskegee Syphilis experiment began In the 1930s, the field of bioethics in clinical research was in its infancy. In reality, it began to take form following the atrocities uncovered at the end of World War II at the hands of the Nazi regime. The Nuremburg War Tribunals during the 1940s allowed for the world to see the inhumanities that were inflicted by the Nazis on their war prisoners, but it also helped to recognize that there was a gap in basic principles and ethics governing the use of humans in clinical research. As an output of these trials, the Nuremburg Code was adopted in 1947 as a group of ten core principles to be used as guidance in human medical experimentation. One of the key principles highlighted in the code was the concept of informed consent by research participants. Per the Nuremburg Code, The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. In the case of the Tuskegee experiment, several of these basic tenets were violated by the investigators involved in this research. Although investigators for the PHS were aware of the outcomes from the Nuremburg Trials, they did not draw parallels between their research on blacks and the unethical treatment of German prisoners who were Anglo. In the instance of the Nazi concentration camps, the Polish and Jewish prisoners were seen as human capital that had been treated inhumanely. Conversely, the black men in the syphilis experiment were viewed by investigators as clinical trial materials, essentially less than human. Some would argue that the men, although coerced by the specter of free and regular medical treatment, participated of their own free will. Syphilis, or bad blood as it was known locally, was endemic in Alabama during this time period, hence the initial interest by the PHS. Combined with a dearth of competent and available medical resources, many welcomed the opportunity to receive treatment for their bad blood through a government sponsored program. However, because most of the subjects were illiterate or unable to understand the medical and scientific terminology used by the investigators, they were not in a position to fully understand the testing and treatment they were to undergo. Beyond just forcibly withholding standard of care treatment from those with active infections, the subjects were tricked into participating in risky and painful spinal tap procedures in order to collect synovial fluid for exploratory tests. The spinal taps offered no medical value to the subjects, yet put them at undue risk for infections and potential for paralysis from ill –performed procedures. Under the pretense that these procedures were an experimental treatment, researchers failed to reveal the potential risks to patients who were already suffering from the impact of non-managed disease progression. Unbeknownst to them, because the men had an untreated active infection, the failure to treat also placed their sexual partners and family members at continued risk for infection.

In addition to the failure to ensure appropriate informed consent, another tragedy was the US governments involvement thru the PHS along with medical professionals who were sworn to do no harm. Both were blamed and both have experienced long-term mistrust. During the 1970s, as the word spread, the story-telling incorrectly evolved into a scenario where the men were purposefully inoculated with syphilis by the government. As such, it weakened its credibility and its public health efforts in the black community. Blacks questioned all information coming from the government, assuming that the information was either untruthful or shielding an ulterior motive. This provided fodder to government conspiracy theorists and shook the trust of the black community that the government represented their best interests. This was further exacerbated by the lack of contrition by the Public Health Service and from the investigators involved the experiment. The mistrust was revisited in the following decade with the introduction of the HIV/AIDS endemic in the African-American community. Many blacks have theorized that the HIV virus was purposely developed to infect African-Americans as a means to promote genocide in the community. Although there was no credible evidence supporting this basis, for some, the fallout from the Tuskegee Experiment gave credence to the theory. In addition to fostering mistrust of the government, the medical staff involved did significant damage to the perception of trustworthiness of the medical professions. While the faces of scientific investigators then and now are generally white, there were indeed black doctors and nurses who also played a role in the experiments. This was dramatized in the 1997 film, Miss Evers Boys, a story based on the real-life involvement of black nurse, Eunice Evers, who supported the syphilis experiments from the beginning in 1932. She, along with black doctors Eugene Dibble and Robert Moton, were vilified for their involvement in the experiment and were held by many to be just as complicit in allowing the atrocities to continue. In totality, the Tuskegee events wedged a wider divide between African-Americans and the medical community, including mistrust for black healthcare providers as well.

 

The Tuskegee Syphilis Experiment represents a dark chapter in the annals of biomedical research in the 20^th century for the United States. We made a step in the right direction as a nation when in 1997, President Bill Clinton issued a formal apology from the U.S. government to the remaining survivors and families. In addition to the apology, the Department of HHS established a monument to the Tuskegee men and created a Center for Bioethics research at Tuskegee University. But will it ever be enough?

Should the US government be doing more to regain the trust of members of the African-American communities, particularly on issues related to Public Health? If so, what?
Is it fair to view the US PHS and their involvement in the Tuskegee experiment through the bioethical lens of the 21^st century? What has changed and what is constant?
Do we expect this to continue to be an issue for the current generation of Millennials, who are now only a couple of generations removed from the Tuskegee experiment? If so, what will it take to close this gap?

 

 

Comments (1)
Where have we been: Part 2: Dawn of Hospital-BasedResearch July 25, 2011Filed under: Where Have We Been clinicalminority @ 7:23 pm
Tags: bioethics, clinical research, iatrophobia, johns hopkins medical school, medical apartheid, night doctors

I call em body snatchers quick they come to fetch ya? With an autopsy ambulance just to dissect ya.

-Public Enemy 911 Is a Joke (1990)

As I was thinking about this post, I was reminded of the Public Enemy song, 911 Is a Joke. The premise of the song was an attempt by the socially-conscious rap group to highlight the issues with rescue services in the late 1980s and early 90s in New York City. Allegedly, emergency services were not reliable or timely in their response time in the lower socio-economic areas of the city, leading to preventable death and injuries in the African-American community. Yet, within the narrative, the group also articulated the perception that many still held that the deaths were intentional in order to create a readily available pool for the body snatchers to generate cadavers for their research. Ultimately, the root cause of the delays was associated with the security concerns that first responders had. However, this still illustrates that a resounding impact of a community often abused, bypassed, overlooked, neglected and offered second-rate care by the U.S. medical system. This trend didnt follow the rise of any musical genre, or the rhyme of any lyrics, but was actually initiated in the late 1890s and carries with it a palpable, resounding impact on the community almost a century later.

With the founding of the Johns Hopkins Hospital in 1889 and the creation of the Johns Hopkins Medical School in 1893, we ushered in a new era in US medicine. Funded primarily by the philanthropic efforts of financier Johns Hopkins, the hospital was one of the first large facilities dedicated to providing health services to the poor. Ahead of its time, Hopkins was progressive for the period in providing services—albeit segregated—to people of color across the wider Baltimore community. In parallel, the founding of Johns Hopkins Medical School (JHMS) at the turn of the century represented a new standard for medical training in this country. Before the introduction of Hopkins rigorous medical training program, the requirements for training physicians were minor, consisting of inconsistent trade school training and apprenticeships. Prior to this period, there was no nationally accepted standard for medical training. JHMS became the first U.S. medical school to establish a bar on entry requirements that included clinical research, introducing the training concept of clinician-scientist. In order to understand disease etiology and progression, the implication of this new clinical standard and respected medical institution was the increased requirement for research subjects achieved through autopsies and viable candidates made available for dissection.

As described by Harriet A. Washington in Medical Apartheid, the need for subjects for anatomical dissection drove researchers to look to the African-American community for an answer. And it was not their opinion that was sought. The commonly held perception by societal standards was that Negroes were expendable humans, if deemed human at all. The term night doctors was coined as a result of those researchers who would steal African-American bodies from graves for their research under the cover of night. It was even suggested that night doctors intentionally killed potential subjects in order to have fresh specimens for their research. Large research hospitals like Johns Hopkins and the University of Pennsylvania even justified any subsequent autopsies and dissections of blacks as payment for medical services they received prior to death. It was such a common occurrence in the 19^th century that black families grew to expect bodies to be missing from their gravesites shortly following their funerals. Unfortunately, there is not a significant amount of written history documenting this phenomenon, as many African-Americans in the antebellum period still were unable read, or at least pretended not to, in order to avoid potential consequences. However, through oral history and anecdotal evidence, African-Americans were acutely aware of the grave-robbing atrocities and stories of blacks being snatched from the streets never to be heard from again.

Considering the level of medical racism rampant during this period, African-Americans became increasingly reluctant to utilize medical services, particularly in the large, hospital setting. As previously discussed, their iatrophobia, or fear of doctors, mounted as a physicians motive was always in question. It was simply difficult to discern whether their interest in preservation of life outweighed their desire to identify viable research candidates. Unfortunately, this fear led to a reluctance of blacks to pursue standard medical treatments in favor of home and herbal remedies or waiting until their discomfort was unbearable. What took root at the time was a perception among minorities that large hospitals and teaching institutions were not places of healing, but where one would only go as a last resort. Ones chances were seen as 50/50, to either die inside those walls or become a guinea pig for their medical research, or both. Ironically, one can see the connection in the African-American community today. There remains a disinclination to seek preventive care and to participate in modern clinical research—both of which ultimately do more harm to minorities and undoubtedly contribute to persistent and debilitating health disparities across the spectrum of disease.

FEEDBACK: Whats your take? Comments are welcomed!

Is medicine unjustly vilified for past indiscretions committed for the good of all?Does the medical profession (including clinical research) promote the persistent hegemony that ultimately bites itself in the butt?Do we have any hope of reversing the beliefs and positions on both sides any time soon?

Comments (1)
Minority Inclusion: 10 Things You Can Do RIGHTNOW! July 7, 2011Filed under: 'Colored' Paper Clinical Ambassador @ 10:48 am

The sun is blazing, the heat is mind-numbing and the Triangle is under a haze. When I couple my summer fever with the multitude of projects underway at Clinical Ambassador, the result is limited lengths of attention to any one thing. So in the spirit of my narrow ability to focus for a long stretch, heres some random — and hopefully thought-provoking — information that you can put to good use:

Here are TEN things you can do RIGHT NOW to improve minority inclusion in YOUR clinical trials. For those of you less inclined to do more work, let me assure you that its well worth it for the return. And for that matter, you can always get a specialist to do the heavy lifting!

Right off the bat:

advertise with specific language on CraigsList (we can provide you with captivating content and headlines)invite members of the kitchen, janitorial, grounds and maintenance crew of your facility to a lunch-n-learn so they understand the work you do (we can provide templates for invitations)send fliers to the local black Greek organizations (we have templates)sponsor or participate in a job fair at the local HBCU (we can set up connections with campus liaisons)identify and reach out to the local advocate related to the therapeutic area your protocol deals with (eg. AIDS, diabetes, heart disease social workerand we can provide a customized list from our database)expand your hours for screening/enrollment for convenience (if not, outsource contact to an agency like us)as much as possible, be mindful of the barriers you build in to your protocols. Loosen your I/E criteria that unnecessarily disqualify people with certain pre-existing conditions (use the cultural competence filter we invented)offer betterand more immediatecash incentives [or offer to pay the rent for three months (we believe in incentives, and we can set that up)]set up links to appear on facebook/twitter/myspace (we can help you link to social networking sites and do the tweeting for you)minor details with major impact: improve the coziness/decor of your facility and the friendliness of your staff and add snacks to your waiting room (get specific ideas or a consult with a diversity designer expert like Clinical Ambassador)For more information, shoot me an email at allison@clinicalambassador.com. Visit our Web site at http://www.clinicalambassador.com.Happy Summer! Now, get to work!AllisonLeave a Comment
COME ON IN. THE WATERSFINE! July 4, 2011Filed under: Where Are We Going Clinical Ambassador @ 2:50 pm
Tags: minority, patient recruitment

The reluctance to stick ones neck out in this arena is understandable, as it is historically rife with socio-political baggage. Nobody wants to step on what they fear is a land mine and expose their lack of cultural competence. And worse yet, in a professionally vulnerable manner. But we know what will happen if the status quo persists: Absolutely nothing.

Be assured of a few things: First, none of us is perfect. We all have work to do. Secondly, this is a no-blame arena, where hostility and harsh tones will not be tolerated. Not on my watch. And third, the primary reason and singular rationale behind starting the group was to provide a platform, a safe space, for frank discussion because there was none.

The Clinical Ambassador blog and the Minority Patient Recruitment LinkedIn professional group are precious few places that encourage candid discourse on the topic. The willingness to discuss the hot-button issues the only means by which were going to make any significant difference in the work that we do. We wont get there from here without putting our preconceptions on display and take the risk. And find solace in knowing that your questions likely mirror those of countless others who have wanted to know the same but were afraid to be put it out there.

But fear not. This is where we get down with resolving problems, not pointing fingers. And boy, do we have work to do.

Our 5 simply rules are these:

1. There is no stupid question. At least well act as if there isnt. And there is no one right answer.
2. Members will respect one another, wherever they are along their cultural competence journey. [And employers are not allowed to smack their employees for raising their hands. We dont bite. And there should be no reprisal at home, either.]
3. Dont expect one person from a minority group to speak for all.
4. If youd rather communicate (with me or others) offline, you certainly may, but it rather defeats the purpose of having a blog.
5. When you actually learn something here, you are absolutely required to pass it on.

Now that thats out of the way, lets get down to business. Isnt that why were here?
So, whos got minority patient recruitment issues we can help with? What are you dealing with?

Leave a Comment
Where have we been: Part 1: Clinical Research in Slavery/Antebellum US July 1, 2011Filed under: Where Have We Been clinicalminority @ 4:10 pm
Tags: clinical research, harriet a. washington, iatrophobia, johns hopkins medical school, medical apartheid, minority, patient recruitment, slavery

The confluence of medical advancement and the slave trade is no mere coincidence. Prior to Africans being introduced into colonial United States, our nations medical system was primitive at best. The geographical proximity of Europeans, Native Americans and Africans in this new nation brought along with it an exposure of each group to new diseases, pathogens, and more virulent forms of even known diseases. This led to the medical establishments burgeoning determination to better understand the etiology (biological pathways) of diseases that led to the creation of new treatments and the development of preventative approaches. Slaves were integral to this process for several reasons. These included, but were not limited to, economic incentive as healthy slaves could bear the burdens of building the new countrys infrastructure, as well as the availability of human slaves for early clinical and social research. Much of this is discussed in author Harriet A. Washingtons research narrative called, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Click on the link above to learn more.

Continue reading below

Pages: 1 2

Leave a Comment
Minorities and Personalized Medicine: Promise (Yet)Unfulfilled June 28, 2011Filed under: Personalized Medicine clinicalminority @ 11:48 pm
Tags: bioethics, clinical research, minority, patient recruitment, Personalized Medicine, pharmacogenomics

Personalized medicine, in simplistic terms, encompasses the use of genetic information to optimize the development of medicines for specific patient populations. Pharmaceutical companies are widely interested in this drug development space, as it would allow them to perform more targeted marketing and create with confidence, drugs that are safe and efficacious for the targeted population.  Personalized medicine has the potential to make the drug development process more efficient, by lowering the attrition rate for drugs and thereby reducing the estimated $1.3 billion it costs to bring a drug to market. For doctors and patients, the benefits are also clear, as the current process of drawing conclusions from large groups of similar patients has proven to be useless and outdated. It’s far better science for healthcare providers to make prescribing decisions based on more diverse patient populations. Additionally, it is expected that targeted medicine will allow for an improved drug response and a reduction in adverse drug reactions. Clear examples of where this has been successful are in the field of oncology. For example, successful drugs have been developed in Breast Cancer for women with genes that over-express the HER2 protein. Through accurate diagnostic screening, this patient population can easily be identified and proactively treated.

Regretfully, there has been a lack of focus on personalized medicine for diseases that disproportionately affect minority communities to date. Very little currently exists in the literature to suggest that the industry has exerted much effort on these marginalized groups. From a public health perspective, this is very disconcerting as there is a significant opportunity to reduce health disparities in these communities. According to a study recently published in the American Journal of Epidemiology, Sarah Hartz and her collaborators investigated potential reasons for a lack of inclusion of African-Americans in genetic research. Per their research, lower participation rates appear to occur based on two broad categories, firstly, reduced interest in genetic research amongst African-Americans and secondly, due to a bias in study designs where homogenous (all the same) populations (i.e. of European descent-only) are emphasized. Although these conclusions were drawn from local research in the St. Louis area, it is supported by similar results across the literature. What are you working on? What solutions are being devised to address each of these areas? Will you be the one to make the appropriate changes?

Increase African-American interest in genetic research. Here’s how:

Establish and maintain contact with potential minority participantsAccurately collect demographic information and utilize it to maintain the relationshipsOvercoming distrust of genetic researchIdentification of Minority Clinical InvestigatorsBuy-in and support from community organizationsProvide education on the benefits and the WIIFM (What’s In It For Me)Utilize cultural competence to translate the need and the results            

Reducing Study Design Bias:

Increase the economic incentive for drug developersReduce ambiguity from NIH/FDA on minority participation requirementsMore rigorous investigation prior to marketing application approval regarding the lack of population data in minoritiesIncrease post-marketing requirements for additional sub-group analyses

More burning questions! What are your thoughts?

What can we do collectively to increase minority participation in clinical research, particularly genetic research that may lead to personalized medicines?

How can we engage pharmaceutical companies to realize the benefits outweigh the costs associated with the added focus on minorities?

How can the regulatory agencies take a more collaborative approach that motivates drug developers to support this cultural shift without the need to implement enforcement activities?

Leave a Comment
Colored Paper: Fear AsMotivator June 23, 2011Filed under: 'Colored' Paper Clinical Ambassador @ 4:48 pm

Within the marginalized (read minority) communities, fear is public enemy number one. Fear—while it can be paralyzing and even hysterical—is a justifiable companion of those who have been exiled, enslaved, oppressed, discriminated against, incarcerated, and killed based on little more than race. For minorities, mere survival has necessitated a certain degree of fear. But fear also underlies our reluctance to take part in clinical trials. We are scared to death that history waits right behind the curtain for its encore.

To be sure, contemporary fears among Black folks about clinical research are rooted in centuries of social injustice—in insidious historical abuses and inequities in the system. Broadly speaking, fear among the African American community accompanies a deep-seated distrust toward the medical establishment based on past institutional exploitations, medical atrocities and a legacy of widespread abuses that can be described in a single utterance: “Tuskegee.” In the final analysis, the Tuskegee experiment did ultimately bestow science with new policies protecting human subjects and led to stringent oversight regulations and safeguards like informed consent and institutional review boards. But Tuskegee also left a monumental legacy of distrust.

Fear contributes to underrepresentation in clinical trials by those who should be able to rely on research for solutions. Ironically, special populations who stand to gain the most from medical advances are often reluctant to avail themselves of it. Blacks and other vulnerable populations reject opportunities to participate in promising interventions that can close these gaps.

Patient recruitment for clinical trials will never be a one-size-fits-all proposition. Not only do we need novel socio-behavioral strategies, but recognize that the most effective strategies will be informed by the populations we’re trying to recruit. Cultural competence is the centerpiece to trust. And not a moment too soon: Not only are disparities widening, but recent medical discoveries show groundbreaking potential and the game-changing shift toward personalized medicine will demand it. If minorities take part in this process, we should expect scientific results with greater integrity and reliability. But we can’t wait for a guarantee. Ain’t no such thing. We have to be open to the facts about clinical research lest we remain mere spectators to progress.

When I relay my own experiences as a study participant, people of color have more than occasionally looked at me a little askance. But I counter that with this simple fact: that we routinely conduct our own one-person studies when we take medications that were not tested on us. The real gamble is not getting involved and staking a claim in the process. The bigger risk is allowing the status quo to remain unchecked.

While scientists acknowledge these obstacles, Ive heard them lament feeling ill-equipped to undo the damage. But fear not. Honesty, transparency and sincerity are work miracles in human communication. Acknowledgement is a vital element in building trust. Continued denial about the past, the system, or negative personal beliefs actually has a worsening effect. And know that discomfort with this subject matter is actually a requisite symptom of an intact conscience, and a perfectly acceptable place to start.

The ultimate paradigm shift will be reflected in a widespread attitude of entitlement that makes medical options, and showing up, pivotal to empowerment. New discoveries are key to survival. We must act as if little else matters. Little else does.

Allison Winfield Kalloo, MPH

Founder CEO, Clinical Ambassador

Leave a Comment
Where are we? May 31, 2011Filed under: Where Are We Now clinicalminority @ 9:56 pm
Tags: bioethics, clinical research, iatrophobia, patient recruitment, Tuskegee syphilis

In todays clinical environment, as a patient, in order to have access to the newest and most innovative drugs, you must participate in clinical trials. However, consistently, African-Americans and Hispanic-Americans are under- represented in clinical research studies. For example, according to the New England Journal of Medicine, African-Americans are 50% less likely to participate in clinical research or have access to experimental treatments than whites. This phenomenon is consistent across multiple therapeutic areas. For instance, although Hispanics and African-Americans represent 65% of the new AIDS cases in the US, their rate of participation in HIV studies is less than 20% on an annualized basis. According to researchers at Rush Medical College, African-Americans have a disparate 40% higher mortality rate from overall cancer when compared to whites, yet are under-represented in National Cancer Institute (NCI) supported trials with only a 9% participation rate.

Continued on the next page

 

Pages: 1 2

Leave a Comment
Next Page
Recent Entries Where Access Meets Accountability: Or, Fame asAnesthesia Henrietta Lacks and HeLa cells: Implications in ClinicalResearch Where have we been: Part 3: “BadBlood” Where have we been: Part 2: Dawn of Hospital-BasedResearch Minority Inclusion: 10 Things You Can Do RIGHTNOW!
Email Subscription
Our TWEETS: This is pivotal. lnkd.in/dBkxzUsr 6hoursago Resilience! lnkd.in/d7_QakjB 7hoursago lnkd.in/djyG6qWh 22hoursago Can we say that were really surprised by their profit model?? lnkd.in/dBSmsDP9 22hoursago Agree!! lnkd.in/dxrEn92D 2daysago
Blogroll Clinical AmbassadorDiscussGet InspiredGet PollingMinority Patient Recruitment Group-LinkedInTwitter: @clnclAMBASSADOR Get a free blog at WordPress.com Release. RSS Comments RSS Create a free website or blog at WordPress.com. Clinical Ambassador-Blog Blog at WordPress.com. Follow Following Clinical Ambassador-Blog Already have a WordPress.com account? Log in now. Clinical Ambassador-Blog Customize Follow Following Sign up Log in Report this content View site in Reader Manage subscriptions Collapse this bar Loading Comments...

TAGS:Blog Ambassador Clinical brokering disparities impacting trust 

<<< Thank you for your visit >>>

brokering trust. impacting disparities.

Hot Websites