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Targeting outreach and prevention efforts for historically marginalized populations and leveraging stakeholder insight and experience to develop appropriate marketing efforts are just 2 of the ways cancer institutes can engage the community in men’s health screenings, according to a session at the Association of Community Cancer Centers (ACCC) 47th Annual Meeting and Cancer Center Business Summit.

Angelo Moore, PhD, MSN, RN, NE-BC, program manager, Office of Health Equity at Duke Cancer Institute, discussed how one of his goals was to truly involve the community in educating others on the clinical guidance, primarily for prostate cancer screenings, since it was not done much in past years.

“Sometimes you have to make some bold changes,” Moore said. “Sometimes when things are done a certain way, people don’t like to change.”

These changes included a different program name, which saw a huge return rate in screenings, according to Moore. The original name was “Men’s Health Initiative,” which caused many people in the community to question what the program was focused on. Moore suggested the name change of “Men’s Health Screening” for a more straight-forward title and better communication with his audience.

In addition, a new multi-pronged marketing strategy was a main focus over the past year, according to Kearston L. Ingraham, MPH, program evaluator at Duke Cancer Institute. Some examples that Ingraham highlighted included creating a marketing committee, printing material in English, Spanish, and Mandarin, and culturally tailored promotional materials to target medically underserved communities.

“Our community partners immensely helped with messaging and getting the word out,” Ingraham said. “We were able to go to different grocery stores, retail stores, and other organizations around the community to continue to spread the word on these screenings.”

Comparing data insights from 2018 to 2019, Ingraham mentioned how men in the older age ranges saw a significant increase and attendance in screenings, showing that many of the marketing initiatives worked. Further, Moore added how the usual return rate is no more than 30%; however, the 2019 data showed a 56% return rate.

Although COVID-19 impacted many organizations negatively, Moore felt that COVID-19 was an opportunity for the Duke Cancer Institute to reach populations that usually are not spoken to.

“We realized that reaching out to these underserved populations, such as Latinx and Asian American, we needed to have translation services in language they understand and interpretation services at an event,” Moore said.

Ingraham KL, Moore A. Hosting a Successful Men’s Health Screening: Strategic Alignment of Health Communication via Culturally Tailored Media, Marketing, and Community Engagement Efforts. Presented at: ACCC 47th Annual Meeting & Cancer Center Business Summit; virtual: March 4, 2021.

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Angelo Moore, PhD, MSN, RN, NE-BC, program manager, Office of Health Equity at Duke Cancer Institute, discussed how one of his goals was to truly involve the community in educating others on the clinical guidance, primarily for prostate cancer screenings.

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Targeted Alignment of Communication Can Improve Uptake of Men's Cancer Screenings in Marginalized Populations

The FDA has issued an emergency use authorization (EUA) for a COVID-19 diagnostic test (T-Detect™ COVID, Adaptive Biotechnologies Corporation) that can confirm recent or prior COVID-19 infection. The diagnostic test is T cell-based and is the first indication for the test, which resulted from a recent collaboration between Adaptive Biotechnologies Corporation and Microsoft.

“People who have been unsure about a prior infection will now have another way to know if they had the virus,” said Chad Robins, chief executive officer of Adaptive Biotechnologies, in a press release. “The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm. We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications.”

The FDA based its assessment of the issuance of the EUA on a clinical validation study that demonstrated that the diagnostic test has a sensitivity of 97.1% through the use of RT-PCR. Since sensitivity is the ability of a diagnostic test to accurately identify a positive case of COVID-19, or present with a true positive, the significant level of sensitivity demonstrates a high level of diagnostic accuracy, according to the FDA.

Additionally, the FDA found that the diagnostic test had a specificity of 100%. Specificity evaluates the test’s ability to accurately identify a negative COVID-19 case, or present with a true negative, and 100% specificity shows the test has complete accuracy in this area.

Although COVID-19 is the first indication for the diagnostic test, it is being developed for multiple disease states. The diagnostic capacity of the T cell-based test is a translation of the diagnostic capability of T cells into the clinical practice domain.

T cells, which are the adaptive immune system’s first responders in the detection of any virus, multiply and circulate in the blood in order to defend the body against a virus upon its detection. Due to their role in the immune system, T cells contain information that may provide a trackable measure of the body’s immune response to COVID-19, as T cells “remember” prior infections in order to more effectively kill pathogens upon reappearance.

Since research has demonstrated that antibodies to SARS-CoV-2 may decline over time, T cells may be a valuable source of information to help researchers assess how long patients remain resistant to reinfection. Because T cells circulate freely in the blood, they are also an easy way to assess exposure to SARS-CoV-2 and potentially immunity as well.

“This is the first commercially available T-cell test that confirms recent or prior SARS-CoV-2 infections in people. T-Detect is accurate and what I find especially remarkable is how rapidly it was developed. Going from the lab to real-world human impact in a matter of months demonstrates the true value of our collaboration and the power of merging biology with cloud-scale machine learning technology,” said Peter Lee, corporate vice president, Research & Incubations, Microsoft, in the press release. “We are hopeful that this technology will have a meaningful impact not only in the global fight against COVID-19, but in many other disease areas in the future.”

Adaptive Biotechnologies Announces FDA Emergency Use Authorization for T-Detect™ COVID to Confirm Recent or Prior COVID-19 Infection. Seattle, WA: Adaptive Biotechnologies Corporation; March 5, 2021. [email] Accessed March 8, 2021.

The FDA has issued an emergency use authorization (EUA) for a COVID-19 diagnostic test that can confirm recent or prior COVID-19 infection. 

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FDA Issues EUA for COVID-19 Diagnostic Test to Confirm Recent or Prior COVID-19 Infection

Researchers at Columbia and MIT have created a new technique that can uncover nearly all of the behaviors that cancer cells use to evade immunotherapies, which could lead to the development of more effective treatments, according to a press release.

The researchers tested the new technique with cancer cells and matching immune cells from melanoma patients and identified previously unknown resistance mechanisms to immune checkpoint inhibitors, which is a widely used class of immunotherapy drugs.

“With drugs called immune checkpoint inhibitors, we’re now getting as close as we have ever been to curing one-third of patients with metastatic melanoma, even at a stage when the disease has spread throughout the body,” said study leader Benjamin Izar, MD, PhD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeonsm, in a press release. “So, the question is, what is happening in the other two-thirds of patients?” Izar says. “What are the mechanisms of intrinsic or adaptive drug resistance?”

 in 2018, Izar and his team identified 250 genes in metastatic melanoma cells that allow them to evade the immunotherapy. This study’s objective was to provide a systematic way to functionally decipher how each of those genes contributes to immunotherapy resistance, according to the press release.

The recent study is the first test of a new tool that combines 2 advanced technologies, CRISPR gene editing technology and single-cell RNA and -protein sequencing. This tool allows researchers to determine the full landscape of how cancer cells can evade the immune system.

Using the CRISPR technology, the research team inactivated the 250 genes to create a mixture of 250 batches of melanoma cells, each with a different mutation. The entire heterogenous population of cancer cells edited by CRISPR were then exposed to T cells, which are the immune cells unleashed by checkpoint inhibitors in patients, according to the study authors.

The cells that resisted being killed by T cells were isolated, and a snapshot of all active processes within these cells was measured using single-cell RNA and protein profiling, which provided a high-resolution molecular map of several gene perturbations resulting in immune escape.

“Our approach is unique in that we study these mechanisms in patient-derived models, and rather than looking at how a gene changes a cell’s phenotype one gene at a time, we were able to study many genes with potential roles in drug resistance in patients in one sweep. It’s the first time that such tools have been used at such a large scale,” Izar said in a press release.

The analysis of approximately a quarter million cells helped identify new mechanisms of resistance to immunotherapy along with mechanisms that were previously known.

“Basically, we recovered the majority of known mechanisms described over the last 10 years, validating that our approach works and giving us confidence that the new findings are important,” Izar said in a press release.

One of the new resistance mechanisms includes a gene called 

 in melanoma cells confers immune escape through three potential mechanisms: impairing activation of T cells, reducing the ability of T cells getting into the tumor, and increasing the production of PD-L1,” said study author Johannes C. Melms, MD in a press release. “Because the 

 gene is not mutated per se but rather just turned off, it raises the possibility that therapies that turn it on could overcome drug resistance in some patients.”

Based on their findings, the researchers plan to develop a way to improve response to immunotherapies. Additionally, future experiments are planned to examine inactive various combinations of cancer cell genes at once.

“In this study, we looked at what happens to cells when only one gene is inactivated,” Melm said in a press release. “But it’s likely that no single gene is sufficient to confer all the types of resistance to immunotherapy that we see in clinical practice.”

Why some melanoma patients do not respond to immunotherapy. Columbia University Irving Medical Center. 

https://www.cuimc.columbia.edu/news/why-some-melanoma-patients-do-not-respond-immunotherapy

. Published March 1, 2021. Accessed March 3, 2021.

Researchers at Columbia and MIT have created a new technique that can uncover nearly all of the behaviors that cancer cells use to evade immunotherapies, which could lead to the development of more effective treatments.

Specialty Pharmacy

New Technique for Cancer Cells Discovered to Evade Immunotherapies

A new study indicates that blocking cell receptors for glucagon, the counter-hormone to insulin, can effectively treat type 1 diabetes (T1D) and type 2 diabetes (T2D) by converting glucagon-producing cells into insulin producers instead, according to findings published online in 

The body’s tissues develop insulin resistance, prompting beta cells to die of exhaustion from secreting excess insulin to allow cells to take in glucose in T2D, whereas beta cells dying from an autoimmune attack occur in T1D. Both diabetes types lead to severely elevated blood sugar levels that eventually cause a host of possible complications, including loss of limbs and eyesight, kidney damage, diabetic coma, and death, according to the study.

Most treatments for diabetes focus on insulin, but hormone glucagon that is produced by alpha cells in the pancreas has not received as much attention as other options. Glucagon binds to receptors on cells in the liver, prompting this organ to secrete glucose. Further, some recent studies have suggested that depleting glucagon or blocking its receptor can help patients with diabetes better manage their glucose levels.

May-Yun Wang, PhD, and her colleagues William L. Holland, PhD, a former assistant professor of internal medicine at UTSW who is now at the University of Utah, and Philipp E. Scherer, PhD, professor of internal medicine and cell biology at UTSW and director of UTSW’s Touchstone Center for Diabetes Research, used monoclonal antibodies—manmade proteins that act like human antibodies and help the immune system identify and neutralize whatever they bind to—against the glucagon receptor in mouse models of diabetes.

The PANIC-ATTAC (pancreatic islet beta-cell apoptosis through targeted activation of caspase 8) model analyzed a genetic mutation that causes beta cells to selectively die off when these mice receive a chemical treatment. Once these animals’ beta cells were depleted, the researchers administered monoclonal antibodies against the glucagon receptor. Weekly treatment with the antibodies substantially lowered the rodents’ blood sugar, an effect that continued even weeks after the treatments stopped, according to the study authors.

Further investigation showed that the number of cells in the pancreas of these animals significantly increased, including beta cells. The research team used a technique called lineage tracing to label their alpha cells. When they followed these alpha cells through rounds of cell divisions, they found that treatment with monoclonal antibodies pushed some of the glucagon-producing alpha cell population to convert into insulin-producing beta cells.

To see whether beta cells could rebound through alpha cell conversion under these circumstances, the research team worked with a different mouse model called nonobese diabetic (NOD) mice, in which their beta cells become depleted through an autoimmune reaction. When these animals were dosed with monoclonal antibodies, the beta cells returned despite active immune cells, according to the study authors.

In a third animal model, the researchers injected human alpha and beta cells into immunodeficient NOD mice, which were enough cells to produce sufficient insulin to make the animals borderline diabetic. When the mice received monoclonal antibodies against the glucagon receptor, their human beta cells increased in number and protected them against diabetes, suggesting this treatment could do the same for humans, according to the study.

Holland notes that being able to push alpha cells to shift to beta cells could be especially promising for type 1 diabetics. “Even after decades of an autoimmune attack on their beta cells, type 1 diabetics will still have plentiful amounts of alpha cells. They aren’t the cells in the pancreas that die,” Holland said in a press release. “If we can harness those alpha cells and convert them into beta cells, it could be a viable treatment for anyone with type 1 diabetes.”

Being able to produce native insulin could hold significant advantages over the insulin injections and pumps used by both T1D and T2D diabetics. Wang hopes that similar monoclonal antibodies will eventually be tested in diabetics in clinical trials.

“Even though type 1 and type 2 diabetics try their very best to keep glucose under control, it fluctuates quite massively throughout the day even with the best state-of-the-art pump,” Wang said in a press release. “Giving them back their own beta cells could help restore much better natural regulation, greatly improving glucose regulation and quality of life.”

Swapping alpha cells for beta cells to treat diabetes. UT Southwestern Medical Center. 

https://www.utsouthwestern.edu/newsroom/articles/year-2021/beta-cells-diabetes.html

Both diabetes types lead to severely elevated blood sugar levels that eventually cause a host of possible complications, including loss of limbs and eyesight, kidney damage, diabetic coma, and death.

Diabetes

New Study Swaps Alpha Cells for Beta Cells to Treat Diabetes

, Lee Greenberger, PhD, chief medical officer of the Leukemia and Lymphoma Society, said the development of chimeric antigen receptor (CAR) T-cell therapies is a major step for the treatment of some cancers.

The current FDA-approved CAR T-cell therapies all target CD19, which Greenberger said is a surface marker on the surface of tumor cells. With these therapies, the engineered T cells are designed to bind to CD19, making these treatment options highly effective for leukemias and lymphomas.

The Leukemia and Lymphoma Society has been investing in CAR T-cell therapy research since the 1990s, Greenberger said, including approximately 15 active grants placed worldwide to improve CAR T-cell therapy. With this research developing quickly, Greenberger said he looks forward to more exciting approvals.

“In fact, I know that these things are basically lined up in the FDA,” Greenberger said. “They’re being considered right now for indolent lymphomas, for multiple myeloma, and I think you’re going to see many advancements in this field to come in the next 5 or 10 years.”

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In a recent interview with Pharmacy Times, Lee Greenberger, PhD, chief medical officer of the Leukemia and Lymphoma Society, said the development of chimeric antigen receptor (CAR) T-cell therapies is a major step for the treatment of some cancers. 

Expert Says CAR T-Cell Therapies Could Make Cancer a Chronic Disease

This week on Pharmacy Times, there are a number of important topics that will be covered and posted throughout the week, including:

A video interview with Mary Koslap-Petraco from NAPNAP about COVID-19 vaccines, specifically when/if children under 16 may get the vaccine.

Representatives from the Academy of Managed Care Pharmacy student chapter at Nova Southeastern University discuss the challenges of remote learning during the coronavirus disease 2019 pandemic.

An article that addresses the role of hospitals in not only vaccinating the public, but also in treating both COVID-19 and non-COVID-19 patients, with the flexibility to manage and adapt to surges in the virus. The article also discusses how hospitals must develop strategies that reduce costs while continuing to provide quality care to meet the immediate needs of patients and health care providers.

This week on Pharmacy Times, there are a number of important topics that will be covered and posted throughout the week.

Pharmacy Times: Week of March 8 Lineup

Studies representing nearly 2 million adults worldwide found that eating about 5 daily servings of fruits and vegetables, in which 2 are fruits and 3 are vegetables, is likely the optimal amount for a longer life, according to new research published in the American Heart Association journal 

According to the study, diets rich in fruits and vegetables help reduce the risk for numerous chronic health conditions that are leading causes of death, including cardiovascular disease and cancer. However, approximately 1 in 10 adults eat enough fruits or vegetables, as reported by the CDC.

“While groups like the American Heart Association recommend four to five servings each of fruits and vegetables daily, consumers likely get inconsistent messages about what defines optimal daily intake of fruits and vegetables such as the recommended amount, and which foods to include and avoid,” said lead study author Dong D. Wang, MD, ScD, an epidemiologist, nutritionist and a member of the medical faculty at Harvard Medical School and Brigham and Women’s Hospital in Boston, in a press release.

Wang and his team analyzed data from the Nurses’ Health Study and the Health Professionals Follow-Up Study, which included more than 100,000 adults who were followed for up to 30 years. Both datasets included detailed dietary information repeatedly collected every 2 to 4 years. Further, for this analysis, researchers also pooled data on fruit and vegetable intake and death from 26 studies that included approximately 1.9 million participants from 29 countries and territories in North and South America, Europe, Asia, Africa, and Australia.

The analysis revealed that intake of approximately 5 servings of fruits and vegetables daily was associated with the lowest risk of death, whereas eating more than 5 servings was not associated with additional benefit. Further, eating approximately 2 servings daily of fruits and 3 servings daily of vegetables was associated with the greatest longevity.

Compared to those who consumed 2 servings of fruit and vegetables per day, participants who consumed 5 servings a day of fruits and vegetable had a 13% lower risk of death from all causes; a 12% lower risk of death from cardiovascular disease, including heart disease and stroke; a 10% lower risk of death from cancer; and a 35% lower risk of death from respiratory disease, such as chronic obstructive pulmonary disease (COPD), according to the study authors.

However, not all foods that one might consider to be fruits and vegetables offered the same benefits. For example, starchy vegetables, fruit juices, and potatoes were not associated with reduced risk of death from all causes or specific chronic diseases. On the other hand, green leafy vegetables and fruit and vegetables rich in beta carotene and vitamin C showed benefits.

“Our analysis in the two cohorts of US men and women yielded results similar to those from 26 cohorts around the world, which supports the biological plausibility of our findings and suggests these findings can be applied to broader populations,” Wang said in a press release.

Wang added that this study identifies an optimal intake level of fruits and vegetables and supports the evidence-based, succinct public health message of “5-a-day,” meaning people should ideally consume 5 servings of fruit and vegetables each day.

“This amount likely offers the most benefit in terms of prevention of major chronic disease and is a relatively achievable intake for the general public,” Wang said in a press release. “We also found that not all fruits and vegetables offer the same degree of benefit, even though current dietary recommendations generally treat all types of fruits and vegetables, including starchy vegetables, fruit juices and potatoes, the same.”

Further, a limitation of the research is that it is observational, showing an association between fruit and vegetable consumption and risk of death, as it does not confer a direct cause-and-effect relationship, according to the study authors.

“The American Heart Association recommends filling at least half your plate with fruits and vegetables at each meal,” said Anne Thorndike, MD, MPH, chair of the American Heart Association’s nutrition committee and an associate professor of medicine at Harvard Medical School in Boston. “This research provides strong evidence for the lifelong benefits of eating fruits and vegetables and suggests a goal amount to consume daily for ideal health. Fruits and vegetables are naturally packaged sources of nutrients that can be included in most meals and snacks, and they are essential for keeping our hearts and bodies healthy.”

The right ‘5-a-day’ mix is 2 fruit and 3 vegetable servings for longer life. American Heart Association. 

https://newsroom.heart.org/news/the-right-5-a-day-mix-is-2-fruit-and-3-vegetable-servings-for-longer-life

. Published March 1, 2021. Accessed March 2, 2021.

According to the study, diets rich in fruits and vegetables help reduce the risk for numerous chronic health conditions that are leading causes of death, including cardiovascular disease and cancer. 

Research Clarifies Optimal Mix of Fruit, Vegetable Servings for Sustained Health

interviewed Chad Landmon, JD, chair of intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider, on the FDA’s emergency use authorization (EUA) process for COVID-19 vaccines, such as the expedited process for the recently authorized Johnson & Johnson COVID-19 vaccine.

So, Chad, how does the EUA process expedite the FDA’s normal approval procedures?

 Sure, thanks for having me today. So, the EUA process at a basic level is expedited, and basically the way this works is it starts with an emergency declaration by the HHS secretary.

The EUA process was put in place actually by various legislation over the years. A lot of it was actually focused early on terrorism aspects and worries of some sort of biological or radiation weapon being used. So over time, the various legislation has addressed how the EUA process works, but at its core it starts with an emergency declaration from the secretary of HHS finding that there's an emergency—some sort of public health emergency, some sort of threat or actual terrorist attack—and then that pretty much puts FDA into motion on how they handle these.

Very generally, it's an expedited process where the agency works very closely with the applicant—often actually the request is made from somebody within the government, so from NIH, from CDC, from FDA to the applicant—and then they work pretty much to expedite all stages of the development.

So, a lot of times, instead of doing things in steps where you complete phase 1, and then you do phase 2, then you do phase 3, a lot of things are kind of done all at the same time to get the review done quicker. There's a lot more interaction between the agency and the companies in terms of what needs to be done, what studies need to be done, how the review process works, and it's really put not only at the top of the queue, but all of FDA's resources are kind of thrown at it in order to get the review done quickly.

Right. How does the speed of the EUA process for COVID-19 vaccines and tests over the past year compare to the normal expected timeline for an EUA or an approval by the FDA?

 Yeah. So as far as EUAs, it's kind of hard to do a comparison. I mean, they all move very quickly, so there's been EUAs in the past for the Zika virus, kind of one of the more recent times where we've had a series of EUAs. But for testing and other things within FDA, they all move very quickly.

I think during COVID-19, we saw some incredibly quick movements on EUAs, particularly as has had to do with PPE and other testing items early on, and then with the vaccines as well. It's hard to say whether it's quicker or slower.

As compared to the normal approval process, I mean it really shaves years off of the approval process and development process. Normally vaccines probably would have gone through a 3 to 5 year development cycle in review by FDA, and as we saw less than a year, if not significantly less than a year, for the review by FDA.

Right. What is the process the agency goes through as it considers whether or not to grant EUAs?

 Yeah. So, it starts by the agency determining first that there's some sort of serious condition or disease that's being treated. It has to also look to see that there are no alternatives out there on the market that can be used that are already approved, and then the standard is very different.

So, a normal approval standard is the agency determining that a vaccine, a treatment, whatever is both safe and effective. The EUA threshold determination is just that the vaccine, the therapy, or whatever it is may be effective, and that's a significant difference. 

Basically, FDA looks at whatever information it has, whatever information through abbreviated clinical studies, or whatever has been done, and it makes a determination that the vaccines, as we've been talking about, that they may be effective in doing what they need to do. So, obviously it's a shorter analysis, it's looking at less information than would go into a full approval or a full review, and FDA then finally kind of does a risk benefit analysis. So, it looks at okay now that we know that it may be effective, then how risky is it. 

So, through the safety studies that have been done, through whatever other information is out there how risky is it, and how beneficial will it be. I mean, obviously with COVID-19 worldwide pandemic, I mean we don't need to get into the extent of the death and loss and everything that's going on, but the risks were obviously very big, so if you look at something that may be effective, you need to do that balancing act, and FDA came out in favor, at least with these vaccines, that the risk benefit analysis was in favor of authorizing these vaccines.

Pharmacy Times® interviewed Chad Landmon, JD, chair of intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider, on the FDA’s EUA process for COVID-19 vaccines.

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How the FDA’s Expedited EUA Process for COVID-19 Vaccines Works 

The CDC has released new guidance for individuals who have been fully vaccinated against COVID-19, saying that they can safely gather with other fully vaccinated people or with unvaccinated people who are at low risk for severe COVID-19.

Although the guidelines still urge vaccinated individuals to wear masks and continue to remain physically distanced in public spaces, the CDC said that vaccinated people can safely visit with others who are vaccinated indoors without wearing masks or physical distancing. When visiting those who are unvaccinated, the guidelines state that vaccinated individuals can visit those from a single household who are at low risk for severe COVID-19 without masks or physical distancing.

Notably, the guidelines also said vaccinated individuals can refrain from quarantining and testing following a known COVID-19 exposure if they are asymptomatic. Regardless of vaccination status, however, those with symptoms consistent with COVID-19 should isolate from others and get tested if indicated.

The guidance said relaxing certain measures for vaccinated individuals may help improve vaccine acceptance and uptake. According to the CDC, individuals are considered fully vaccinated 2 weeks after they have received the second dose in a 2-dose series or 2 weeks after receiving a single-dose vaccine. Indoor visits in which everyone is fully vaccinated present a low risk. For this reason, the guidance said masks and physical distancing are not necessary in small, fully vaccinated groups.

Visits and small gatherings likely pose minimal risk to fully vaccinated people, the guidance said, although larger groups and those including unvaccinated people from multiple households increase the risk of COVID-19 transmission. Vaccinated people should still be mindful of potentially spreading the virus to others, especially those who are unvaccinated or at increased risk for severe illness from COVID-19.

Because vaccinated individuals are likely at low risk, the guidelines said the level of precautions taken should be determined by the characteristics of the unvaccinated people. For example, masks should still be worn around older adults or those at high risk of severe COVID-19, and physical distancing should still be maintained. Notably, everyone in the group should take these precautions, including those who are fully vaccinated.

Risks during other activities outside the home, such as eating at a restaurant or going to the gym, are also lower for vaccinated individuals. However, the guidelines said precautions should still be taken to prevent transmission of COVID-19 to unvaccinated individuals. These precautions include wearing a well-fitting mask, maintaining at least 6 feet of space between people, avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, and washing hands frequently.

Interim Public Health Recommendations for Fully Vaccinated People. CDC; Updated March 8, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

The guidance said relaxing certain measures for vaccinated individuals may help improve COVID-19 vaccine acceptance and uptake.

CDC Guidance Says Individuals Fully Vaccinated Against COVID-19 Can Safely Gather Indoors Without Masks, Physical Distancing

 suggests that women who attend their 2 most recent breast cancer screening appointments prior to a breast cancer diagnosis had some protection against cancer-related death.

According to a press release, women who participated in both of their previous 2 screenings had a 50% lower incidence of their breast cancer proving fatal within 10 years of diagnosis, compared to women who did not attend either of the last 2 screenings. Compared to women who attended only 1 of the previous 2 screenings, women who attended both had a 22% to 23% reduction in breast cancer mortality.1

Of the 549,091 women who were included in the analysis, 392,135 women participated in both previous screenings. There were 41,746 intermittent participants, 30,945 lapsed participants, and 84,265 serial nonparticipants. Among the entire group, a total of 2589 cancers proved fatal within 10 years.2

“While there is ample evidence that breast cancer mortality is reduced in those who attend screening, these results demonstrate that repeated attendance confers greater protection than attendance at a single screen,” said lead author Stephen Duffy, BSc, in a press release. “We need to ensure that the screening experience is as stress-free as possible, so that people will come back.”1

The study, conducted by researchers at Queen Mary University of London, included more than 500,000 Swedish women and was conducted over 24 years. In the press release, principal investigator Laszlo Tabar, MD, FACR, said the research was conducted in 9 Swedish counties and added that the findings reinforce the value of early detection efforts.1

“This work adds additional evidence confirming the value of early detection of breast cancer through regular attendance at mammography screening, helping women and their physicians make informed decisions,” Tabar said in the news release.1



Attending consecutive mammography screens protects against breast cancer death [news release]. EurekAlert; March 3, 202 

https://www.eurekalert.org/pub_releases/2021-03/qmuo-acm03032php

Duffy S, Tabar L, Yen A, Dean P, et al. Beneficial Effect of Consecutive Screening Mammography Examinations on Mortality from Breast Cancer: A Prospective Study. 

https://pubs.rsna.org/doi/10.1148/radiol.2021203935

Women who attended the 2 more recent screenings prior to their breast cancer diagnosis had a 50% lower incidence of their cancer being fatal within 10 years.

Study: Attending Consecutive Mammography Screenings Prior to Breast Cancer Diagnosis Protects Against Death

For women continuing therapy for multiple sclerosis (MS) throughout pregnancy, new research suggests that adherence to their disease-modifying therapies (DMTs) can result in lower hospitalization rates and costs compared to women who discontinued their therapy.

The retrospective study, conducted by Walgreens in collaboration with AllianceRx Walgreens Prime, aimed to understand how non-adherence to DMTs affected health care costs and utilization over a 2-year period.

According to the study, an estimated 2.3 million people worldwide have MS, and women are affected 2 to 3 times as often as men. None of the common therapies for MS are approved for use during pregnancy, according to the National MS Society, although discontinuing treatment with DMTs may cause relapse. Earlier research has found that some patients do continue receiving their therapies if advised to do so by their health care provider, according to the current study.

“When it comes to pregnancy or thinking of becoming pregnant, a key discussion on the risks and benefits of DMT therapy must take place between the patient and provider,” said Kathleen Love, RN, a clinical program manager at AllianceRx Walgreens Prime, in a press release.

The researchers demonstrated in a previous study that adherence among MS patients to DMT medications can reduce both hospitalization events and their related costs, according to the press release. In the study, Heather Kirkham, PhD, MPH, director of health analytics, research, and reporting at Walgreens, said the earlier, broader study looked at all patients with MS rather than just pregnant women.

“We examined the experience of MS patients not specific to pregnancy and their health care utilization and total health care cost,” Kirkham said in the news release. “We decided to look at this subset of patients because they might have a different experience. In the broader study, we did see a relationship between patients who are more adherent having a lower total health care cost.”

Using Market Scan commercial claims data over a 3-year period from 2014 to 2017, the research team identified MS-diagnosed women and followed their pattern of treatment from outpatient and inpatient visits, as well as DMT therapy, over 2 consecutive years. They created cohorts for those who received pregnancy services in the first or second year of follow-up, according to their DMT utilization. With a DMT medication adherence metric, the team identified patients as adherent to DMT in just 1 of the years or for both years.

“This was a retrospective observational study, with levels of patient DMT adherence segmented into number of years adherent or not, with outcomes on total adjusted medical costs (inpatient or outpatient non-maternity services), DMT costs and associated MS medication costs,” said Francis Staskon, PhD, senior analyst of health analytics, research, and reporting at Walgreens, in the press release.

According to the study results, among the women who utilized maternity services, 82.7% were in the first-year follow-up period. Of the 500 first-year pregnancies, 79% discontinued DMT utilization into their second year. Analysis of 603 patients’ DMT utilization found that 9.2% were adherent in both years, 39.9% were adherent in 1 year, and 53.9% were non-adherent in both years.

Furthermore, comorbidities such as diabetes or chronic pulmonary disease were present among 48 patients. Patients who were consistently adherent had significantly lower adjusted medical costs compared to consistently non-adherent patients or those with mixed adherence.

According to Staskon, these findings demonstrate that pregnant women with MS typically reduce their DMT medication adherence, but a significant number do continue treatment and demonstrate good adherence levels. Notably, average non-maternity medical costs for adherent patients were significantly lower compared to other 2 DMT non-adherent or discontinued patient groups.

The study findings also validate the importance of clinical interventions, such as those that support medication adherence, adverse effect management, symptom management, and additional counseling or information that can be provided by pharmacists.

“MS is so unpredictable and unique per individual,” Love said in the press release. “There are so many choices now for patients with MS, and a very key component in therapy along the continuum of their life is their discussion about their DMT with their prescriber.”




Study demonstrates adherence to disease-modifying therapies in pregnant MS patients can reduce hospitalization events [news release]. AllianceRx Walgreens Prime; March 1, 2021. 

https://alliancerxwp.com/contents/press-releases/study-demonstrates-adherence-to.html

Study findings demonstrate the importance of interventions for multiple sclerosis therapy, such as those supporting medication adherence, adverse effect management, symptom management, and additional counseling.

Medication Adherence in Pregnant Women With MS Can Reduce Hospitalizations

Practice Pearl 2: Risks and Benefits of the Role of DOACs for Prevention of VTE

A panel of experts discuss the risks vs benefits of prophylactic care for patients to prevent VTE.

Practice Pearls

When ‘the pill’ became legal almost 50 years ago, there was hope for many people that we were on our way to opening the doors of opportunity and autonomy for women. While there has been progress, efforts to restrict access to basic health care are ever more present. Given their accessibility and expertise, pharmacists are ideally positioned to provide patients with the necessary information and guidance regarding contraception. However, whether to allow a pharmacist to provide contraception is up to the states and while lawmakers wrestle with various issues women are left waiting.

Illinois has been working to expand access to contraception for women. For instance, Illinois requires insurance to cover a 12-month supply of contraception and state law protects contraceptive coverage.

 In addition, Illinois has expanded Medicaid access to low-income adults.

 The Illinois legislature is also considering pending legislation led by State Representative Michelle Mussman and others that would allow pharmacists to provide contraception directly to women. All these steps and more would mitigate challenges some women in Illinois face.

Contraception access is problematic for women living in rural and urban Illinois. Doctor visits to acquire a prescription for contraception are sometimes unnecessary but most often costly. In addition to the time off from work, the cost of transportation and cost of child-care can make contraception cost-prohibited for women with limited means. Allowing women to get their contraception directly from a pharmacist is even more important during the pandemic when people are seeking safe and convenient access points for health care.This is already a reality at more than 3000 pharmacies across the country.

Further complicating the issue is the fact that more than 780,000 women in Illinois live in contraceptive deserts—counties in which there is not reasonable access to a health center offering the full range of contraceptive methods.2An already challenging contraceptive access landscape has been made more difficult by loss in Title X funding, as a result of the 2019 domestic gag rule. The rule, which is opposed by the American Medical Association, includes language aimed at limiting abortion as a legal medical option. According to Power to Decide, a nonprofit campaign to prevent unplanned pregnancy, one third of Illinois counties have lost some or all of their Title X resources.

Contraception plays an important role in women’s lives and has broad public support. The majority of adults 76%),believe that birth control is a basic part of women’s health care. Further, 86% of adults support access to all birth control methods regardless of race, region, and political affiliation

Allowing pharmacists to provide contraception increases access to basic health care that is safe and allows women to plan for their futures. As R Street Institute, a right of center think thank has indicated, “… Illinois should consider implementing the pharmacy access model to allow pharmacists to prescribe birth control to patients seeking a provider. This model has already passed and is working in a number of states since 2015, and it is time for Illinois to follow suit.”

Women in Illinois need access to vital preventative health care services, and pharmacists may soon play a larger role in providing them. Pharmacists can also support the efforts of those who are working out legislation technicalities with insurance companies and medical associations in order to make contraception affordable and accessible in Illinois.

Beyond the Beltway. Power to Decide. Published January 1, 2021. Accessed February 9, 2021. 

https://powertodecide.org/sites/default/files/2021-01/Pharmacist%20Prescribing.pdf

Contraceptive Access in Illinois. Power to Decide. Published March 16, 2020. Accessed February 9, 2021. 

https://powertodecide.org/sites/default/files/2020-03/State%20Factsheet_Illinois.pdf

Protecting Contraceptive Coverage. Power to Decide. Accessed February 9, 2021.

https://powertodecide.org/what-we-do/access/state-policy/rh-access-policies/protecting-coverage

Gov. Pritzker signs Medicaid expansion, increased transparency in Illinois. 

https://www.kfvs12.com/2019/08/05/gov-pritzker-signs-medicaid-expansion-increased-transparency-illinois/

Pharmacist Prescribing of Contraception.Power to Decide. Accessed February 9, 2021.

https://powertodecide.org/what-we-do/access/state-policy/rh-access-policies/pharmacist-prescribing

Bill Status of HB0135. Illinois General Assembly; Updated February 23, 2021. Accessed March 8, 2021. 

https://ilga.gov/legislation/BillStatus.asp?GA=102&SessionID=110&DocTypeID=HB&DocNum=135

There's a new birth control doctor in your neighborhood. Birth Control Pharmacies. Accessed February 9, 2021. 

Impacts of The Domestic Gag Rule. Power to Decide. Accessed February 9, 2021. 

https://powertodecide.org/sites/default/files/2020-10/Impacts%20of%20the%20Domestic%20Gag%20Rule_Factsheet.pdf

https://powertodecide.org/what-we-do/information/resource-library/contraceptive-access-illinois

Survey Says: #ThxBirthControl (November 2019).

https://powertodecide.org/what-we-do/information/resource-library/survey-says-thxbirthcontrol-november-2019

Pharmacy Access to Contraception in Illinois. 

https://www.rstreet.org/wp-content/uploads/2019/04/Final-Illinois-Pharmacy-Access-R-Sheet-2019.pdf

The Illinois legislature is considering pending legislation that would allow pharmacists to provide contraception directly to women.

Women's Health

Illinois Working on Expanding Access to Contraception for Women

The FDA has approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.1 The regulatory decision was based on data from the phase 2 ZUMA-5 trial (NCT03105336), in which the CAR T-cell product elicited a response in 91% of patients with relapsed/refractory follicular lymphoma (n = 81); this included 60% of patients who achieved a complete remission (CR).

Notably, 74% of patients had a continued remission at 18 months. Among all patients with follicular lymphoma, the median duration of response (DOR) was not yet reached at a median follow-up of 14.5 months.

“Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy,” Caron A. Jacobson, MD, MMSc, medical director of the Immune Effector Cell Therapy Program at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, stated in a press release. “Additionally, for patients with follicular lymphoma in the third line of therapy, the 5-year survival rate is only 20%, highlighting the urgent need for treatments that offer a real chance for durable remission. Impressively, 91% of [these] patients in the ZUMA-5 study responded to a single infusion of axicabtagene ciloleucel, including an estimated 74% of patients in a continued remission at 18 months, giving these patients much-needed hope and oncologists an important addition to the treatment armamentarium.”

The single-arm, open-label, multicenter trial enrolled 146 patients with either relapsed or refractory follicular lymphoma and marginal zone lymphoma who had previously received 2 or more lines of systemic therapy, including treatment with an anti-CD20 monoclonal antibody and an alkylating agent.

The FDA has approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

Hematology

Axi-Cel Granted Accelerated Approval for Relapsed/Refractory Indolent Follicular Lymphoma

The American Society of Health-System Pharmacists (ASHP) has issued a statement urging widespread use and acceptance of all vaccines currently approved by the FDA to combat SARS-CoV-2. The statement also calls for these vaccines to be distributed equitably based on the greatest public health impact and irrespective of geographic or economic status.

“ASHP’s position is that all 3 FDA-authorized vaccines have–based on the available evidence–proven efficacious in preventing serious illness, hospitalization, and death from COVID-19," said Daniel J. Cobaugh, PharmD, DABAT, FAACT, vice president of publishing and editor-in-chief of the 

American Journal of Health-System Pharmacy

, in a prepared statement. “Individuals should obtain whichever vaccine is immediately available to them to protect themselves and others from COVID-19, support the establishment of herd immunity, and effectively respond to the pandemic.”

In their statement, ASHP argues that each vaccine has been proven effective in reducing severe symptoms, decreasing hospitalizations, and decreasing death from COVID-19, and that it is therefore imperative to ensure they are distributed and accepted with haste. The organization cites fears of vaccine hesitancy and misinformation based on antivaccine myths and urges health care professionals to message confidence in all of the currently approved vaccines.

ASHP also states that there is no acceptable reason to allocate a vaccine based only on population differences or socioeconomic status. They argue that, as each vaccine has demonstrated a benefit to all populations evaluated for the emergency use authorization by the FDA, it is paramount that they are distributed based on where they will have the greatest public health impact and not simply based on logistical ease or the wealth of the populations in question.

ASHP, a 79-year-old organization representing pharmacists who serve as patient care providers in acute and ambulatory settings, intends to evaluate claims of vaccine efficacy and educate on COVID-19 vaccine safety. The society produces scientific content designed to drive optimal medication use and health outcomes, and they plan to assess the advantages and disadvantages of each vaccine in different populations.

ASHP urges widespread use, equitable allocation of FDA-authorized COVID-19 vaccines [news release]. ASHP; March 5, 2021. Accessed March 8, 2021. 

https://www.ashp.org/news/2021/03/05/ashp-urges-widespread-use-equitable-allocation-of-fda-authorized-covid19-vaccines

In their statement, ASHP argues that each vaccine has been proven effective in reducing severe symptoms, decreasing hospitalizations, and decreasing death from COVID-19. 

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