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The US Food and Drug Administration (FDA) approved a supplemental indication for phentermine and topiramate extended-release capsules (Qsymia) for chronic weight management in pediatric patients 12 years and older who defined as having a body mass index (BMI) of 95th percentile or greater when standardized for age and sex.

The approval, which was was supported by data from a 56-week trial involving 223 obese individuals 12-17 years old, recommended capsules be used in conjunction with a reduced-calorie diet and increased physical activity.

A total of 54 patients were randomly assigned to the Qsymia 7.5 mg group, while 15 were enrolled in the 15 mg group and 56 in the placebo group.

All participants were counselled in lifestyle modification, which included reducing calories and increasing physical activity.

Overall, participants in the 7.5 mg and 15 mg treatment groups lost an overage of 4.8% and 7.1% of their BMI, respectively. Meanwhile, those who were on placebo gained an average of 3.3% of their BMI.

Back in 2012, the FDA approved phentermine and topiramate extended-release capsules for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater with at least 1 weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia, as an adjunct to a reduced-calorie diet and increased physical activity.

The capsules are only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy (REMS), due to the increased risk for birth defects with fetal exposure to Qsymia during pregnancy,

Phentermine and topiramate extended-release capsules are also associated with increased heart rate, suicidal behavior and ideation, depression, the slowing of linear growth, acute myopia, secondary angle closure glaucoma, mood and sleep disorders, cognitive impairment, metabolic acidosis, and decrease in renal function.

The most common adverse reactions reported in the pediatric clinical trial included depression, dizziness, joint pain, fever, flu, and ankle sprain.

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The approval, which was was supported by data from a 56-week trial involving 223 obese individuals 12-17 years old, recommended the capsules be used in conjunction with a reduced-calorie diet and increased physical activity.

FDA Approves Phentermine and Topiramate Capsules for Pediatric Chronic Weight Management

The Cleveland Clinic’s Charles Modlin, MD, 

 in the summer of 2018 to discuss he and his colleagues to bridge minority communities to better healthcare access. And at the time, he challenged his peers to embrace this as another one of their responsibilities: to find the means to end healthcare disparity.

“The onus is on us to develop alternative ways to communicate with people, engage with people, empower people, and respect that in many instances people have cultural differences,” he said.

Sadly, few things have bettered in that great venture over the last 2 years—just as things hadn’t bettered in the last 50. In the same conversation, Modlin quoted Rev. Martin Luther King, Jr., a man well before his time, with similar goals to similar problems:

“Of all the forms of inequality, injustice in health care is the most shocking and inhumane.”

This week’s turn of events, continuing in protests and acts of violence across the streets of most major US cities and towns in response to the killing of George Floyd during an arrest by officers with the Minneapolis Police Department, has sparked strong and swift response from almost every major national medical organization.

The responses have been uniform in their stances against racism in action, the advocation for changes to currently-held standards for justice and equality, and the reiteration that Modlin’s, King’s, and so many other’s fight against healthcare disparity is unfinished—and worth seeing through.

American Academy of Emergency Medicine (AAEM)

Here is a highlight of statements to come from some organizations familiar to the 

AAEM Releases Statement with SAEM on the Death of George Floyd

“As emergency physicians, when a human being says, "I can't breathe," our immediate response is a call to action to save a life. We have committed our lives to reducing disparities in the emergency department and to providing compassionate, unconditional care for all who need it, regardless of race, ethnicity, creed, gender, sexual orientation, physical ability, or any other human factor.&#8239;

American Academy of Family Physicians (AAFP)

"Unfortunately, as emergency physicians, we also know all too well that racism is a public health crisis and a national plague. We, all too often, see its devastating effects, most recently in the disproportionate COVID-19 deaths of people of color due in part to the long-standing health inequities that continue to exist.”

“As a health care organization, the AAFP considers racism a public health crisis. The elimination of health disparities will not be achieved without first acknowledging racism’s contribution to health and social inequalities. This includes inequitable access to quality health care services. Our members see the negative health outcomes of racism in their patients who are often at an increased risk of heart disease, stroke, diabetes, low birth weight, premature birth and infant mortality.

Association of American Medical Colleges (AAMC)

“Family physicians are uniquely woven into the social fabric of their respective communities. We take seriously our mission to ensure that all of our patients and their families feel valued and respected as equal members of society. We support family physicians in their efforts to actively dismantle implicit racist and discriminatory institutional practices in their communities.”

AAMC Statement on Police Brutality and Racism in America and Their Impact on Health

“As healers and educators of the next generation of physicians and scientists, the people of America’s medical schools and teaching hospitals bear the responsibility to ameliorate factors that negatively affect the health of our patients and communities: poverty, education, access to transportation, healthy food, and health care.

"Racism is antithetical to the oaths and moral responsibilities we accepted as health professionals who have dedicated our lives to advancing the health of all, especially those who live in vulnerable communities.”

Statement on Death of George Floyd and Its Aftermath

American College of Gastroenterology (ACG)

"The profession of ophthalmology and individual ophthalmologists are committed to providing compassionate, equitable and outstanding care for all patients and communities. We rededicate ourselves individually and collectively to that mission and to building a society of fairness, justice and opportunity for all. There is no place for racism."

“As clinicians, we understand that our humanity is defined by how we treat others. Caring for people who are vulnerable is the core of our profession and supporting each other with kindness and understanding while promoting inclusion and equity is who we are.

"This is why we must not remain silent. Racism, bigotry or discrimination of any form cannot be tolerated and when it occurs, should not be ignored.”

Internists “Gravely Concerned” About Discrimination and Violence by Public Authorities and Others

"It is evident that African-Americans in particular are at risk of being subjected to discrimination and violence against them because of their race, endangering them and even costing them their lives. This should never be acceptable and those responsible must be held accountable. ACP has long held that hate crimes, prejudice, discrimination, harassment and violence against any person based on race, ethnicity, religion, gender, gender identity, sex, sexual orientation, or country of origin is a public health issue."

What does the life — and death – of George Floyd, Breonna Taylor and Ahmaud Arbery mean for the health of Blacks in America?

AHA, Association of Black Cardiologists (ABC), and American College of Cardiology (ACC)

“Racial disparities in heart disease also exist. Recent research shows that heart disease risk actually differs among African Americans, blacks from the Caribbean and African immigrants: American blacks have a higher level of cardiovascular risk. What we hear from this science is that race itself is not a risk factor. Rather, deep societal ills are hurting the hearts of black men and women in our nation.”

Joint statement on health equity, social justice and civil unrest from the Association of Black Cardiologists, the American Heart Association and the American College of Cardiology

"Like cardiovascular disease, acts of violence and racism are core causes of psychosocial stress that promote poor well-being and cardiovascular health, especially for communities of color.

"Given that heart disease and stroke are the leading causes of death for communities of color, particularly African-Americans who have the lowest life-expectancy of all racial/ethnic groups living in the United States, we are extremely disturbed by violent acts that cut to the core of the lives of our community.

"Therefore, along with other leading health organizations, we DENOUNCE incidents of racism and violence that continue to ravage our communities.”

When you can’t breathe, nothing else matters.

"Too many breaths have been lost — from George Floyd, Breonna Taylor, Ahmaud Arbery and so many more. The American Lung Association denounces all forms of institutional racism and acts of racial violence. What is happening in our communities today, and has happened for decades, is unacceptable.

"As we join our fellow Americans to mourn for the loss of black lives, both from racial violence and the pandemic, we acknowledge how our humanity is linked, and that truly, every breath is precious. We stand ready to listen and work with individuals and organizations to create a more just world."

APA Condemns Racism in All Forms, Calls for End to Racial Inequalities in U.S.

“The APA believes that all forms of racism and racial discrimination affect mental health and well-being and negatively impact the nation as a whole. We must fight racism in all its forms, embracing multiculturalism, diversity, and greater inclusion.

"The APA stresses that anyone who is suffering trauma because of the death of George Floyd, or the civil unrest ongoing in America or health inequalities, to seek psychiatric treatment. Our members are standing by to help.”

ASH/ASH RC/CMSS Statement on Racism in Healthcare

“The American Society of Hematology and ASH Research Collaborative stand in unity with the CMSS and the 800,000 physicians across 45 medical specialties that deplore the negative impact of racism in our nation and of racial inequities in our healthcare system.&#8239;Racism in our society cannot be ignored as it undermines public health.”

“The ASN is proud of its efforts to promote diversity, equity, and inclusion among kidney health professionals. This commitment is hollow, however, if ASN fails to oppose racism. ASN strongly supports and will advance efforts to achieve equality to reduce the adverse impact of racism, especially on health and in health care.

"Of the more than 37 million people with kidney diseases in the United States, a disproportionate number are of African, Latino, and Native American descent. The COVID-19 pandemic is worsening health disparities and social determinants of health, especially for people with kidney diseases.”

ATS Responds to the Death of George Floyd and Subsequent Events

American College of Chest Physicians (CHEST)

“As a professional society, it is also important that we have an active voice in the ongoing debate that is racking the United States; the debate surrounding racial intolerance is once more at the forefront of our consciousness. Racism has been brought into sharp focus once again, as we are made aware of the racially-based disparities in healthcare delivery and outcomes that have become painfully obvious in the wake of the COVID-19 pandemic. These disparities are at the core of the tragic events unfolding in Minneapolis and in other cities throughout the country.”

The Society for Healthcare Epidemiology of America (SHEA)

“We celebrate the diversity of our members and of the patients we treat. In our caring for others, we must do more than strive to be free of racism, bigotry, and discrimination. We must acknowledge that social injustice has a physical, emotional, and psychological impact on our patients’ health. We must continue to educate ourselves on the effects racism and socioeconomic disparity have on our patients of color. We must understand and overcome our own implicit biases if we are to build bonds of trust. And we must be a voice for change.”

Statement from the Society for Healthcare Epidemiology of America on the Public Health Concerns of People of Color

“The violent interactions between law enforcement officers and the public, particularly people of color, combined with the disproportionate impact of COVID-19 on these same communities, puts in perspective the overall public health consequences of these actions and overall health inequity in the US.

"SHEA’s vision is safe healthcare for all. All violence, particularly that perpetrated by law enforcement, elevates the stress that our communities are already facing in the midst of the COVID-19 pandemic. SHEA strongly champions equitable healthcare for everyone in the US and for ongoing research and resources to work to address these inequalities.”

The most recent protests to police brutality, and the ensuing violence across cities and towns, sparked response from most national medical institutions&mdash;who for decades have sought to address disparities in care.

US Medical Groups Share Front Against Racism, Healthcare Disparity

An original version of this article was published on sister publication Contagion®.

The US Food and Drug Administration (FDA) has issued an emergency use authorization for a new rapid point-of-care molecular SARS-CoV-2 diagnostic.

The test, which was developed by Abbott, delivers positive results for COVID-19 infection in 5 minutes, and negative results in 13 minutes, according to a 

The newly approved test utilizes Abbott's ID NOW platform, a portable 6.6-pound device. The ID NOW platform is already in standard use in the United States as a molecular point-of-care device for influenza A and B, Strep A, and respiratory syncytial virus.

The COVID-19 test will be available within days, with Abbott's manufacturing capacity prepared to deliver 50,000 tests per day, the company noted.

"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," Robert B. Ford, president and chief operating officer, Abbott, said in the statement. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."

The process for using the new test involves placing the sample in a chemical solution, to release genetic material by breaking down the virus. The ID NOW platform then uses isothermal amplification of identified nucleic acids, to allow for detection of the virus. For the test, the diagnostics targets the 

"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the frontlines, where testing capabilities are needed most," Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott, said in an article posted to the 

. "Portable molecular testing expands the country's capacity to get people answers faster."

Earlier this month, Abbott received emergency authorization for a 

. Upon approval, the company was capable of shipping 180,000 of these tests, which uses the m2000 RealTime System. Between these two approved tests, Abbott is prepared to produce 5 million tests for COVID-19 in April, according to the company.

"This is [a] game changer," said former FDA commissioner 

. "It’s very likely that we’ll see additional approvals of point-of-care diagnostics behind this one, extending testing to doctor offices across the United States."

As of March 27, 2020, the FDA had issued over 19 emergency use authorizations for COVID-19 diagnostics, 

. Additionally, over 110 laboratories have begun testing for the virus under policies put in place by the agency.

At the time of this article, there were over 600,000 globally reported confirmed cases of COVID-19 infection, with the number rapidly growing in the United States to beyond 100,000.

Additional novel diagnostics are expected to enter the market through the FDA's emergency authorization program in the next weeks.

For the most recent case counts in the COVID-19 outbreak, check out the 

The Abbott-developed test platform is already used as a molecular point-of-care device for influenza A and B, Strep A, and respiratory syncytial virus.

FDA Authorizes Five-Minute COVID-19 Test

An original version of this article was published by sister publication ContagionLive.

 virus a person is exposed to in early childhood impacts their ability to fight flu for life, according to recent study findings.

The phenomenon is known as antigenic imprinting.

Matthew Miller, PhD, and a team of investigators examined the Canadian flu season of 2018-19, which was unusual in that both strains of influenza A dominated at different points. During the 2019 winter, H3N2 viruses progressively replaced H1N1 viruses as the dominant subtype.

Miller, an associate professor at the Michael G. DeGroote Institute for Infectious Disease, and colleagues employed sentinel data from the Institut National de Santé Publique du Québec (INSPQ). INSPQ reports weekly counts of positive test samples for influenza A and B strains by age group, which allowed investigators to assess whether people born in different years might be susceptible to different flu strains.

In order to estimate weekly rates of influenza A by age group, the total cases for each period under observation were divided by total population for each group in Québec.

The results showed that even without direct data on subtype dominance, the progressive shift could be captured by looking at the distribution of influenza A cases by age, with a shift in age-specific incidence as the subtype dominance changed observed. Younger individuals displayed increased susceptibility to H1N1 relative to H3N2, and H3N2 disproportionately targeted older individuals.

“These results are consistent with the antigenic imprinting hypothesis: during the 2017-18 and 2018-19 seasons, individuals aged 40-49 years were born in 1968-78 and in 1969-79, respectively, and were thus most likely imprinted by H3N2,” the study authors wrote.

It appears that individuals are less susceptible to influenza during seasons which feature the same predominant strain that they were first exposed to.

Future research may be able to investigate transmission dynamics within households to examine how imprinting may affect the transmission of strains within families. The results of the recent study could have useful public health implications down the line.

“Understanding how their prior immunity either leaves them protected or susceptible is really important for helping us to identify the populations who are most at risk during seasonal epidemics and new outbreaks," Matthew Miller said in 

Age-specific incidence of influenza A responds to change in virus subtype dominance

,” was published online in the journal 

Younger patients display increased susceptibility to H1N1 relative to H3N2, according to study findings.