Immunotherapy Approvals by the FDA

I wanted to repost this list of FDA approvals of immunotherapeutics that blogger, Brad Loncar has published (***). I made a word cloud of his results and, as expected, Keytruda (pembrolizumab) and Opivid (nivolumab) had the greatest hits for therapies. In recent years the PD-1 inhibitor, Keytruda, has galvanized the immunotherapy field. Keytruda has been found to show indications in advanced non-small cell lung cancer, advanced melanoma, head and neck squamous cell carcinoma, Hodgkin lymphoma, and advanced urothelia bladder cancer. Hopefully, more malignancies can be targeted by Keytruda, along with other drugs.

Minority Participation in Clinical Trials

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The other day some friends/acquaintances and I were randomly chatting about clinical trials. I say that the chat was “random,” because many of these people are not scientists and scientific topics rarely come up in these chats. Then, the story took another random twist into the area about minority groups that are involved in these trials. This twist was more comedic in nature, like would women be considered for participation in a clinical trial for prostate cancer. I wrote this entry, because I wanted to throw my thoughts and interpretations about the lack of minority enrollment in various clinical trials.

Jokes aside, why is this topic so important?

Based on statistics from the U.S. Census, the minority population was 38% of the total U.S. population in 2014; however, the minority population is expected to rise to 56% by 2060. Although minorities currently make up more than a third of the U.S. population, minorities make up less than 10% of patients enrolled in clinical trials, according to the National Institutes of Health (NIH) National Institute on Minority Health and Health Disparities. The major concern with these trials is that many illnesses are observed at a disproportionately higher rate in minority communities. Due to lower enrollment and participation, the data from these trials are limited in terms of effectiveness of treatments and may not represent the best approaches for treatment. There are several factors that may be attributed to this issue, which include lack trust of the medical community, lower incomes, less education, and greater hurdles for accessing healthcare.

In my opinion (I know that others would agree), I think distrust of the medical community and reduced access to adequate healthcare are the two most important factors affecting the enrollment of minorities in clinical trials.

Lack of trust

It is no secret that many people (in addition to minorities) has serious trust issues for towards the medical community. We are well familiar with the Tuskegee study, in which African American men with syphilis were left untreated well after it was discovered that syphilis could be cured in early stages. Although that travesty occurred in the mid 1900’s, the negative ramifications of this study (and other stores of minority medical exploitation, e.g. Henrietta Lacks) are still ingrained in the minds of African Americans. med apartheidHarriet Washington’s book “Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present” articulates the extreme nature of these notorious (and often useless) medical experiments.

Another potential reason for this distrust is due to the fact that physicians do not look like the people they are serving. Although we have made great racial strides as a country, race and racial bias are still major issues in this country. Typically, many minorities prefer to be examined by people who look like them. Perhaps, a minority patient may feel that the physician will be more empathetic to his/her medical concerns than a non-minority physician. The problem with this rationale is that minorities do not make up a large percentage of practicing physicians serving these communities. In a report from HealthDay Reporter, the percentages of African American and Hispanic practicing physicians are 4 percent and 5 percent, respectively. This statistic shows that there is a large gap between the minority U.S. population and minority physicians.

Access to healthcare

Although distrust is a major issue, I think the lack of access to healthcare is a bigger issue that must be tackled, in regards to clinical trial participation. Since many minorities live within a lower socioeconomic bracket, it is harder for these populations to visit specialists that may inform them of beneficial clinical trials. For example, many minorities have to visit lower quality community health centers where multitude of patients is a great burden for many of the physicians. In a waiting room of 50 patients, I do not think that a physician will have the time and energy to explain every potential treatment that may help one particular patient.

Since many people within these populations also live in lower-income neighborhoods, it is harder for potential clinical trial participants to even visit the health center where the studies are held. If a clinical study requires a long-term commitment with multiple checkups and site visits, this patient may not be able to enroll or complete it, because he/she cannot take time off from work, afford transportation to and from the site, or pay for extra hours of child care.  Since socioeconomic status and education level typically go hand in hand, many members of these populations may not fully understand how participation in the trials would help them and others. This hurdle especially is noticeable if the patient does not speak (or has limited knowledge of) English.

Although I have painted a somewhat grim picture, there are ways to increase the participation of minorities in clinical trials. There have been several outreach programs that will advertise these trials in churches, barbershops, language- or ethnic-specific newspapers and radio stations.  Also, the National Cancer Institute (NCI) recently funded a patient navigator program to assist in the education and enrollment of minorities in clinical trials. Specifically, these patient navigators take the burden off of primary physicians and nurses by meeting with potential trial participants, explaining the trial to the participants, and helping the participants fill out appropriate consent forms. A study in the Journal of Oncology Practice (June 2016) concluded that African American clinical trial participants were twice more like to stay in these trials when assisted with patient navigators. Even though this is a well thought out initiative, there still are issues about initially informing the patient about a potential clinical trial.

Hopefully, the medical community, through various methods of outreach, will continue its efforts in recruiting more minorities for clinical trials. Increased minority participation in these trials potentially will not only help the patient suffering from a particular illness but also provide a better overall public health.