Women seeking help for unmet needs often overdue for cervical cancer screenings

More than half of cervical cancer cases in the United States occur in women who have not had timely Pap smears and/or HPV tests — screenings that allow for detection of precancerous or cancerous cells on the cervix. Encouraging low-income women in particular to participate in such screenings likely would improve cancer detection and save lives, but health-care professionals have been uncertain of how best to improve patient adherence to screenings and follow-ups involving abnormal results.

Women with low incomes sometimes skip Pap smears and other cancer prevention screenings because they are focused on more pressing needs such as housing, food and other necessary expenses. So, researchers at Washington University School of Medicine in St. Louis evaluated efforts to help such women obtain cervical cancer screenings.

The scientists studied a group of female callers in Missouri seeking assistance from a free and confidential phone service that helps people find basic resources. The researchers determined that many female callers were due for cervical cancer screenings but most did not schedule one, even with the support of a health navigator, an individual trained to help people access medical care. Their findings indicate a new, more involved approach is needed to achieve such screenings and, ultimately, lower the number of women treated for advanced cancer.

“Reasons for inadequate screening are many and often deeply rooted to social and structural determinants of health that drive health inequities,” said first author Lindsay Kuroki, MD, an assistant professor of obstetrics & gynecology. “We wanted to determine the need for cervical cancer screening among women seeking assistance with unmet basic needs and to assess different methods of encouraging callers to seek Pap screening. Connecting underserved women to cervical cancer-screening services and assisting them with barriers to access medical care can improve health equity and reduce cancer disparities.“

The findings are available online in the American Journal of Obstetrics & Gynecology.

Participants were recruited from June 2010 through June 2012 from among callers to United Way 2-1-1 Missouri, a telephone helpline for local health and social service resources. Most callers seek help with basic needs such as food, utility bills, shelter and unexpected expenses.

Of 932 callers, 211 were referred for cervical cancer screenings. Callers were randomized to one of three conditions: phone call only; phone call and a print reminder; or a phone call and a personal navigator. The researchers looked at how many women contacted a clinic to schedule a Pap test one month after receiving a referral.

Patients in need of Pap screening had multiple cervical cancer risk factors. These women had a mean age of 48.2 years, were predominantly non-white, poor and unemployed, not married, and actively smoking. Nearly all (94.7%) female callers, regardless of their need for Pap testing, had at least one unmet basic need, with callers reporting an average of two unmet needs.

Women in the group that was assigned health navigators reported higher rates of contacting Pap services (29.6%) than those given phone calls only (15.1%), or phone calls and tailored print reminders (13.4%). Health navigators tripled the likelihood that women made contact with Pap services, and this remained true even among women with multiple unmet needs. Nevertheless, only 41 of 211 (19.4%) women who were overdue for Pap testing and received a referral contacted the referred clinic to schedule cervical cancer screenings.

The scientists said future research is necessary to understand how unmet basic needs pose barriers to cervical screening and how effective interventions to meet basic needs may lead to improved access to cancer prevention services. Some of these interventions might include immediate help such as assisting women with transportation and childcare. Other interventions might focus on redesigning health systems and influencing social policy to provide women at risk for cervical cancer with secure homes free of hunger and tobacco.

“Women contacting 2-1-1 are likely to have health needs that greatly exceed those of the general population, in addition to lacking financial resources and social support required to seek cervical cancer screening,” said senior author Matthew Kreuter, PhD, the Kahn Family Professor of Public Health at the Brown School. “Continuing this line of research is critical to improving outcomes for low-income, medically underserved populations. No woman should die from a preventable cancer.”

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Shocking New Facts Reveal why You Should ALWAYS Sleep at Work

It’s time to put the myth to sleep. The Spanish didn’t really invent siestas as we know them, they just perfected the practice. The word siesta has its origins from the Latin word sexta. In days gone past, the Romans stopped to eat and rest in the sixth hour of the day.

The Spanish have historically had peculiar working hours, with time, they managed to slot in a couple of hours to nap in their daily routines. Their culture supports a practice called presenteeism, which translates to spending more work hours to give the impression of being busy and committed to the workplace. Traditionally, most companies believed that spending more hours at work meant improved productivity. Whilst this is not necessarily always the case, the introduction of afternoon siestas between 2-5pm did allow them to rejuvenate and carry on with their daily activities.

Power Naps

For the siesta to survive in the new age, many things need to be taken into consideration. The sleeping culture of big cities needs to be revised in order to ensure compatibility with the workforce.

There have already been a few initiatives among the Spanish populace to save siesta sessions. Last year sleep pods were tried out in Madrid’s Atocha train station to offer a temporary lunch break relief for tired office work.

An app known as SiestAPP has also been developed to help users refresh and revitalize. The app works by letting users grab some precious 40 winks and then waking them up just in time to get back to work.

In the New Age, people are paid by the Hour, Napping in the Afternoon may thus not make sense for most employers

Downtime

When we take breaks and/or sleep, the brain engages in mundane but important activities. Scientists have always suspected that when one is not actively engaged in a learning experience, the brain strives to amalgamate new data. It is during this time that memory gets stored up and the brain gets to subconsciously rehearse new skills by etching them into the brain tissue.

Most students can give testimony to the fact that after a late night out studying, they were able to recall most of the things learnt in the morning after a good night of sleep. Musicians practicing instruments also experience this same phenomenon. In essence, a good sleep session is an essential component of memory.

Psychology

Psychologists have established that taking breaks and vacations can have real advantages for most people. A vacation takes the mind out of focus on particular issues and helps it concentrate on new things.

Taking a quick shower on a hot day can have the same benefits as a good sleep session. By distracting the mind and giving it a new pre-occupation, different parts of the brain responsible for creativity and memory are triggered. This can have a great benefit in how we are able to execute work much more efficiently afterward.

Siestas allow the brain to switch off for a while and take inventory of the day’s happenings whilst preparing us for future functionality with improved effectiveness

Hobbits

In Tolkien’s Middle Earth magnum opus, the Hobbits are known to partake in two breakfasts, the first and the second. The same way pre-industrial Europe was known to have a first and second sleep session typically divided by an hour of crepuscular activity. Numerous studies have shown that taking naps helps the brain sharpen concentration and improve productivity at workplaces.

A good downtime session can significantly help improve the attention span of people

While there are a couple of forward-thinking companies in the US that allow workers to take naps at the office, most still don’t cater for such needs. A good alternative for those unable to take naps at the office space because of their bosses would be to spend some time outdoors exploring. By taking our minds off work and school for short periods, we’re able to prepare the brain for intensive information processing later in the day.

A good downtime session can help improve the attention span of individuals too. Sleep and meditation are considered to be some great ways to help the mind focus on issues we deem important when we’re feeling a bit fatigued. A nap a day, keeps the productivity at an all-time high. It’s the miracle cure that seems too good to be true, yet still, it is.

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The Role of Nutrition in Health

It is currently estimated that about half of all American adults have one or more preventable and diet-related chronic diseases, the most common of which include cardiovascular disease and type 2 diabetes. As the rate of these chronic diseases, which are often due to poor nutritional intake and physical inactivity, continues to climb, it is imperative that the role of nutrition in all aspects of health is fully understood.

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A nutritionally adequate diet

Most developed nations in the world have federal agencies that provide detailed guidelines on dietary and nutritional recommendations for the general public.

A Guide to a Healthy Lifestyle

Within the United States, for example, the U.S. Departments of Health and Human Services (HHS) along with the U.S. Departments of Agriculture (USDA) publish a joint report every 5 years on the latest nutritional guidelines, whereas the Scientific Advisory Committee on Nutrition (SACN) provides dietary guidelines for citizens of the United Kingdom.

Some of the basic dietary guidelines outlined by the U.S. report recommend a diet that includes:

  • A range of vegetables, including dark green, orange and red vegetables, legumes, and starchy vegetables
  • Fruits, particularly whole fruits
  • Grains, particularly whole grains
  • Fat-free or low-fat dairy products, such as yogurt, milk, cheeses and/or fortified soy products
  • Protein foods, including lean meats and poultry, seafood, legumes, seeds, nuts, and soy products
  • Oils

In addition to providing information on the different types of food products that should be incorporated into each individual’s overall eating pattern, the U.S. dietary guidelines also recommend limiting intake of:

  • Saturated fats
  • Trans fats
  • Added sugars
  • Sodium

To ensure that each individual is following a healthy eating pattern, it is generally recommended that a variety of nutrient-dense foods across all recommended food groups are consumed in their recommended amounts. By consuming these food products, the overall goal is to ensure that an adequate amount of vitamins, minerals, water carbohydrates, proteins, fats and other nutrients are present to support the cells and tissues without the body.

What is malnutrition?

According to the World Health Organization (WHO), malnutrition is a cellular imbalance that arises between the body’s supply of nutrient and energy sources and the physical demand for these components. This imbalance can reduce the body’s ability to grow and maintain adequate operation of various bodily functions. As a result, malnutrition can lead to a compromised health condition and increase an individual’s risk of several different health conditions.

Malnutrition can be further classified into two broad forms, of which include undernutrition and micronutrient-related malnutrition. Undernutrition can be further divided into four forms that include wasting, stunting, underweight, and deficiencies in vitamins and minerals.

Comparatively, some of the different micronutrient-related malnutrition conditions include obesity and being overweight, diet-related non-communicable diseases, and an inadequate consumption of micronutrients.

Undernutrition

Wasting, which can also be defined as an individual with a low weight for their height, often occurs when said individual has recently lost a significant amount of waste. This severe weight loss can be due to a lack of food consumption, or as a result of an infectious disease, such as diarrhea.

Stunting, which is also known as low height-for-age, is a form of malnutrition that is due to chronic or recurrent undernutrition. Stunting is often associated with poor socioeconomic conditions, poor maternal health and nutrition, frequent illness and/or undernutrition in infants and young children.

Deficiencies in vitamin A, iron, iodine, and zinc are some of the most common outcomes of undernutrition. Vitamin A deficiency (VAD), for example, is the most common cause of preventable blindness and also increases an individual’s risk of serious complications following an illness. In fact, it is currently estimated that VAD is responsible for 630,000 infectious deaths, particularly those due to measles, diarrhea, and malaria, each year.

A lack of both meat and plant consumption can lead to an iron deficiency, which can affect the body’s ability to bind and transport oxygen, regulate cell growth and differentiation, and reduce immune function. Comparatively, an iodine deficiency can inhibit normal thyroid functions that are needed for the regulation of growth, development, and metabolic processes, as well as in the prevention of goiter and cretinism. Furthermore, iodine deficiency disorders (IDD) have also been associated with fetal loss, stillbirth, congenital anomalies, and impaired hearing capabilities.

The role of food in health | Dr Rupy Aujla | TEDxBristol

Micronutrient-related nutrition

An individual who is obese or overweight is considered to be too heavy for his or her height. More specifically, a body mass index (BMI) for an individual who is overweight is typically over 25, whereas an obese individual will often have a BMI greater than 30. Since the early 2000s, abdominal obesity has affected about 50% of all American adults, with its prevalence increasing with age. It is currently estimated that 2.3 billion children and adults are overweight in the world.

The double burden of malnutrition is used to describe the paradox that exists between undernourishment and obesity. Although an obese individual may not appear to be malnourished, they often lack a diet that is rich in fruits, vegetables, whole grains and beans, all of which are necessary to maintain an adequate nutritional status.

In addition to increasing their risk of a number of health conditions such as cardiovascular diseases (CVD), diabetes and hypertension, obesity and malnutrition can also increase an individual’s risk of experiencing various forms of cognitive impairment.

Conclusion

Despite the vast socioeconomic disparities that are present between many nations throughout the world, every single country on Earth is affected by some form of malnutrition. Therefore, ensuring that every person consumes a nutritionally adequate diet is imperative to any global health challenge.

A Guide to Looking After Your Mental Health

In general, an optimized nutritional intake that is initiated early in life has been shown to offer the best opportunity for long-term health benefits. Malnutrition not only increases an individual’s susceptibility to a wide range of health conditions, but is also associated with reduced productivity and economic growth, both of which can further contribute to the cycle of poverty and health problems in affected communities.

References

  • Dietary Guidelines for Americans 2015-2020 Eighth Edition [Online]. Available from: https://health.gov/sites/default/files/2019-09/2015-2020_Dietary_Guidelines.pdf.
  • Gondivkar, S. M., Gadbail, A. R., Gondivkar, R. S., et al. (2019). Nutrition and oral health. Disease-a-Month 65(6); 147-154. doi:10.1016/.j.disamonth.2018.09.009.
  • Adan, R. A. H., van der Beek, E. M., Buitelaar, J. K., et al. (2019). Nutritional psychiatry: Towards improving mental health by what you eat. European Neuropsychopharmacology 29(12); 1321-1332. doi:10.1016/j.euroneuro.2019.10.011.
  • Malnutrition [Online]. Available from: https://www.who.int/news-room/fact-sheets/detail/malnutrition.
  • Caulfield LE, Richard SA, Rivera JA, et al. Stunting, Wasting, and Micronutrient Deficiency Disorders. In: Jamison DT, Breman JG, Measham AR, et al., editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Chapter 28. Available from: https://www.ncbi.nlm.nih.gov/books/NBK11761/Co-published by Oxford University Press, New York.
  • Malnutrition Hits The Obese As Well As The Underfed [Online]. Available from: https://www.npr.org/sections/goatsandsoda/2019/12/23/785566796/malnutrition-hits-the-obese-as-well-as-the-underfed.

Further Reading

  • All Nutrition Content
  • Macrominerals and Trace Minerals in the Diet
  • What is Clean Eating?
  • Nutritional / Dietary Supplement
  • Diet Supplements and Liver Problems
More…

Last Updated: Apr 6, 2021

Written by

Benedette Cuffari

After completing her Bachelor of Science in Toxicology with two minors in Spanish and Chemistry in 2016, Benedette continued her studies to complete her Master of Science in Toxicology in May of 2018.During graduate school, Benedette investigated the dermatotoxicity of mechlorethamine and bendamustine; two nitrogen mustard alkylating agents that are used in anticancer therapy.

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Democrats Eye Medicare Negotiations to Lower Drug Prices

Democrats, newly in control of Congress and the White House, are united behind an idea that Republican lawmakers and major drugmakers fiercely oppose: empowering the Department of Health and Human Services to negotiate the prices of brand-name drugs covered by Medicare.

But they do not have enough votes without Republican support in the Senate for the legislation they hope will lower the price consumers pay for prescription drugs. That raises the possibility that Democrats will use a legislative tactic called reconciliation, as they did to pass President Joe Biden’s covid relief package, or even eliminate the Senate filibuster to keep their promise to voters.

Regardless, Democrats hope to authorize Medicare negotiations on payments for at least some of the most expensive brand-name drugs and to base those prices on the drugs’ clinical benefits. Such a measure could put Republicans in the uncomfortable position of opposing an idea that most voters from both parties generally support.

As chairman of a health and retirement subcommittee, Sen. Bernie Sanders (I-Vt.) on Tuesday was set to hold one of this Congress’ first hearings on drug prices, seen as a way for Sanders and his allies to highlight that drug prices in the United States are among the highest in the world.

Dr. Aaron Kesselheim, a Harvard Medical School professor who researches the drug industry and will testify at the hearing, said there is no practical reason the federal government cannot negotiate a price based on independent assessments of a drug’s clinical benefits — as every other industrialized nation, and even some state Medicaid programs, do.

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“The real reason is the drug industry’s lobbying power,” he said.

Negotiating Medicare drug prices has ebbed and flowed as a political issue for years, repeatedly defeated in Congress under pressure from the pharmaceutical industry. The government has been banned from negotiating Medicare drug prices since the creation of the Part D prescription drug benefit in 2006. Instead, the optional private plans through which Americans get Medicare drug benefits negotiate with drugmakers.

It has been two years since Congress summoned executives from Big Pharma companies and pharmacy benefit plans to Capitol Hill for a scolding over skyrocketing prices and the loopholes and secretive contracts they use to block competitors and secure profits.

Despite then-President Donald Trump’s keen interest in lowering drug prices, most proposals by both Democrats and Republicans on Capitol Hill went nowhere under Republican leaders, who argue government intrusion in the free market would hamper future innovation. They point to an estimate from the Congressional Budget Office suggesting the cuts to drugmakers’ revenue under Medicare negotiations could lead to nearly 40 fewer new drugs being developed in the next 20 years.

The government currently approves about 30 drugs per year.

The drug industry, bolstered by its quick efforts to develop a vaccine, has seen public opinion turn in its favor after several years of sharp declines. In early 2020, before the pandemic shut down much of the United States, only about one-third of Americans rated the industry positively, according to a Harris public opinion poll. In February, as vaccination efforts ramped up, about 62% rated it positively — a larger turnaround than any other industry in the past year.

PhRMA, the lobbying organization that represents brand-name drugmakers, came out strong this month against the administration’s first drug-pricing action, a measure in Biden’s sprawling covid relief package that is expected to result in drugmakers paying higher rebates to state Medicaid programs for their drugs.

Brian Newell, a PhRMA spokesperson, suggested the fight is just beginning for Democrats. “The American people reject government price setting when they realize it will lead to fewer new cures and treatments and less access to medicines,” Newell said in a statement. “Our industry has partnered closely with policymakers in fighting the pandemic, and we hope they will partner with us to develop solutions that will lower drug costs for patients, protect access to life-saving medicines and preserve future innovation.”

The Power of Negotiation

Though they disagree on some of the details, such as how far penalties should go, Democrats are united on the need to address drug pricing. Biden, progressives like Sanders and moderates such as Sen. Joe Manchin (D-W.Va.) support proposals that would generally allow the government to set restrictions on brand-name drugs. Researchers say these drugs, initially priced without any competition or regulation, are a leading factor driving up costs for Americans, their employers and the government.

In 2019, the Democratic-controlled House passed legislation that would allow the secretary of Health and Human Services to negotiate the prices for at least 25 of the most expensive drugs marketed in the United States that lack at least one competitor — prices that could be available to people insured by private plans as well. Senate Republicans refused to consider the bill, arguing the policy would discourage drug development.

Top Democrats, including Sen. Ron Wyden of Oregon, chairman of the Senate Finance Committee, say that is likely to be incorporated into drug-pricing reform this year.

Under the 2019 House bill, the negotiated price could not exceed 120% of the highest price in one of six other industrialized nations. Drugmakers would face escalating penalties for not complying.

Sanders and some Democrats took a slightly different path in the previous Congress, sponsoring a package that would enable Medicare negotiations, as well as allow the importation of drugs and broadly tie drug prices to median drug prices in Canada, the United Kingdom, France, Germany and Japan.

But party leaders prefer the House proposal for negotiating prices as a model for this year’s efforts.

In addition to allowing negotiated payments for drugs, Democrats also want to cap prices so they could not rise faster than inflation and limit how much Medicare beneficiaries pay out-of-pocket each year.

Democrats say there are more savings to be gained through giving negotiating power to the government, which would have more heft than any individual plan. In 2017, Medicare accounted for about 30% of the nation’s total retail spending on prescription drugs, according to KFF.

Advocates of Medicare negotiation often cite the Veterans Health Administration as a possible model, noting the government already negotiates with drugmakers on behalf of retired service members and often secures drug prices that are about 35% lower than those paid by Medicare beneficiaries.

Flashback to 2019

Fresh off the campaign trail and invigorated by polls showing about 8 in 10 Americans believe drug prices are unreasonable, senior lawmakers from both parties called the leaders of brand-name drugmakers and pharmacy benefit managers to testify about rising drug costs in early 2019.

That year saw a wave of bills introduced, the most ambitious of which constrained the cost of brand-name drugs through direct price controls. Trump, who bucked his party and supported Medicare negotiation and other price-setting measures, offered a series of changes that mostly fell apart under court challenges.

Sen. Chuck Grassley (R-Iowa) and Wyden, then the chairman and top Democrat on the Finance Committee, respectively, unveiled a proposal that, among other measures, would cap the price Medicare pays for brand-name drugs to the pace of inflation and trigger rebates if prices rise too quickly.

Medicaid already uses a similar inflation cap — and tends to pay lower prices on drugs than Medicare. The HHS inspector general has said Medicare could collect billions of dollars from the drug industry if it followed Medicaid’s lead.

But other Republicans refused to support Grassley on the bill, saying inflation caps amount to government intrusion in the free market, and Republican leaders never brought it up for a vote. Even Wyden said he was not sure he could vote for the proposal unless he was afforded an opportunity to offer a broader cost-containment measure, including price negotiation.

“We’re not going to sit by while opportunities for seniors to use their bargaining power in Medicare are frittered away,” Wyden said at the time.

The former legislative partners are still pushing the issue. Grassley has continued to press lawmakers to consider the earlier bill. Wyden has said he intends to “build off the bipartisan work” he did with Grassley and work with the House-passed Medicare negotiation bill as Democrats consider a reform package this year.

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BXCL501

BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders

NEW HAVEN, Conn., March 11, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the Company has completed the rolling submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. BXCL501 is the Company’s proprietary, investigational, orally dissolving thin film formulation of dexmedetomidine (“Dex”). The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

“This submission is a significant achievement for BioXcel, having taken this program from its first-in-human trial to NDA submission in just over 2 years,” commented Vimal Mehta, Chief Executive Officer of BioXcel. “BXCL501 was discovered using our innovative AI platform and we believe, if approved, could provide health professionals and patients with a fast acting, orally dissolving treatment option. We look forward to hearing back from the FDA and continuing with our commercial preparations to potentially bring a novel product that is designed to treat agitation associated with schizophrenia and bipolar disorders I and II to the U.S. market.”

The submission is supported by data from two randomized, double-blinded, placebo-controlled, parallel group Phase 3 studies (SERENITY I & SERENITY II) of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively. In both studies, BXCL501 was well tolerated and met the primary and secondary endpoints at the 120 mcg and 180 mcg doses, showing statistical significance versus placebo in mean change across multiple agitation scales.

About Schizophrenia and Bipolar Disorder Related Agitation

Agitation is a common and difficult to manage symptom associated with multiple neuropsychiatric conditions, including schizophrenia and bipolar disorders I and II. These two disease states alone have an estimated U.S. prevalence of approximately 9 million adults with more than 3 million experiencing agitation each year. On average, patients with these conditions experience more than a dozen episodes per year, the majority requiring pharmacologic treatment. Early identification and prompt intervention to relieve agitation are essential to avoid symptomatic escalation and the emergence of aggression. Expert consensus best-practice guidelines have recommended that agitation should be treated by a combination of behavioral calming techniques, verbal de-escalation, and medications that are voluntarily accepted by patients without coercion, with the pharmacologic goal of “calming without excessive sedation.” A non-invasive therapy that causes rapid and sustained symptom relief may be helpful to avoid the costly and traumatic use of coercive techniques, like physical restraint and seclusion, which may result in admission and prolonged hospitalization.

About BXCL501

BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. This product candidate is also currently being evaluated in a Phase 1b/2 trial (RELEASE) for the treatment of opioid withdrawal symptoms and in a Phase 2 trial (PLACIDITY) for the treatment of delirium related agitation.

BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the clinical benefits of BXCL501 to treat agitation. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon BioXcel’s current expectations and various assumptions. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.

BioXcel may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BioXcel’s product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of our website at www.bioxceltherapeutics.com.

These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While BioXcel may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing BioXcel’s views as of any date subsequent to the date of this press release.

Source: BioXcel Therapeutics

Posted: March 2021

BXCL501 (dexmedetomidine) FDA Approval History

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Alzheimer’s Disease and Smell Loss

Anosmia (smell loss) or hyposmia (reduced smell) could be an early and important sign of Alzheimer’s disease before other symptoms begin. The degree of smell loss may correlate with an increased risk of developing Alzheimer’s. Anosmia may worsen as the disease progresses from early-stage mild cognitive impairment to Alzheimer’s disease.

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Alzheimer’s disease is the most common form of dementia worldwide. Central to the pathology is the atrophy (shrinkage) of the brain, especially the hippocampus and cortex caused by neuronal & synaptic loss. Neuronal loss occurs due to a build-up of amyloid-beta plaques and neurofibrillary tangles of hyperphosphorylated-tau – two key pathological hallmarks in Alzheimer’s disease.

Whilst Alzheimer’s disease symptoms are obvious as the disease progresses, early detection may be important in slowing down the disease – especially with the continued development of novel therapies or better disease management from early on. The problem, however, is that early detection (biomarkers) is limited or difficult to assess in the clinic and a firm diagnosis can only be made after extensive clinical, neuroimaging, pathological and post-mortem analysis.

Smell loss in Alzheimer’s disease

One American study found that older individuals (around 3000 people aged between 57-85) with impaired smell (hyposmia) had over 2 times the odds of developing dementia within 5 years, independent of other risk factors. Those with the poorest smell discrimination (complete anosmia) were the most likely to develop dementia within 5 years. The degree of olfactory deficit correlated with the severity of dementia that occurred i.e., small deficit related to mild cognitive impairment vs healthy controls, and high degree of deficit related to Alzheimer’s.

Of all those assessed, 4.1% were subsequently diagnosed with dementia within 5 years of which 47% had olfactory dysfunction at the initial evaluation. This was in contrast to 80% of all those assessed who had normal olfactory function who did not develop dementia within 5 years. Furthermore, a meta-analysis of 39 studies showed a large effect size (Cohens d=1.73) was reported between smell loss and Alzheimer’s disease, though there is a high degree of heterogeneity – especially between MCI and Alzheimer’s with respect to smell loss.

Although smell loss is not often considered to be a key symptom of Alzheimer’s disease, it is, however, one of the earliest symptoms to present in patients (if it occurs). It is also important to note that smell loss alone is not a sufficient indication of Alzheimer’s disease, and is indeed also found in many other neurological conditions including early on in Parkinson’s disease in particular, as well as in multiple sclerosis, amyotrophic lateral sclerosis and Huntington’s disease.

The development of disease-specific odor tests is vital in differentiating between diseases – if at all possible (more research is needed at this stage). Nonetheless, smell loss is an important symptom that occurs in a variety of neurological conditions (as discussed). Thus, if odor tests show impairments, it would be important to administer standard tests such as MMSE alongside neuroimaging as a robust method in evaluating the earliest stages of Alzheimer’s.

Furthermore, hyposmia (impaired smell) can also be attributed to normal aging, however, the extent of hyposmia or anosmia, especially earlier than what would be expected as part of normal aging is a strong indicator of the increased likelihood of developing dementia within a few years from the start of such symptoms – before any noticeable cognitive impairments begin to occur.

What causes smell loss to occur in Alzheimer’s disease?

Just as amyloid plaques and neurofibrillary tangles contribute to neuronal and synaptic loss in the brain itself, they are also thought to be causative in olfactory dysfunction. It is thought that neuropathology occurs in regions such as the olfactory system begins prior to impairments within the hippocampus and cortex. Furthermore, the olfactory system has limited self-repair mechanisms thus making it more vulnerable to Alzheimer-related damage.

Based on these findings, a simple discriminatory odor test may be able to evaluate the risk of Alzheimer’s disease (or other neurological conditions) before disease symptoms begin to appear. These could then be validated by other diagnostic tools such as clinical tests, biomarkers and neuroimaging, etc. Early identification can lead to early intervention with a higher chance of improved prognosis and a long-term plan put in place.

In summary, smell loss could be an early and important biomarker of Alzheimer’s disease that occurs before any noticeable cognitive impairments begin. Those with smell loss in mid-age have an increased likelihood of developing Alzheimer’s within a decade, and those with the most impairments to smell (complete loss) are at the highest risk. Therefore, smell discrimination tests could be an easy and effective measure in evaluating the potential for Alzheimer’s disease to develop and allow for early interventions and management plans.

References

  • Kotecha et al, 2018. Olfactory Dysfunction as a Global Biomarker for Sniffing out Alzheimer's Disease: A Meta-Analysis. Biosensors (Basel). 8(2):41. https://pubmed.ncbi.nlm.nih.gov/29652815/
  • Adams et al, 2018. Olfactory Dysfunction Predicts Subsequent Dementia in Older U.S. Adults. J Am Geriatr Soc. 66(1):140-144. https://pubmed.ncbi.nlm.nih.gov/28944467/

Further Reading

  • All Alzheimer's Disease Content
  • Alzheimer’s Disease | Definition, Causes, Diagnosis & Treatment
  • Alzheimer’s Disease Causes
  • Alzheimer’s Disease Symptoms
  • Alzheimer’s Disease Diagnosis
More…

Last Updated: Mar 17, 2021

Written by

Dr. Osman Shabir

Osman is a Postdoctoral Research Associate at the University of Sheffield studying the impact of cardiovascular disease (atherosclerosis) on neurovascular function in vascular dementia and Alzheimer's disease using pre-clinical models and neuroimaging techniques. He is based in the Department of Infection, Immunity & Cardiovascular Disease in the Faculty of Medicine at Sheffield.

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Schizophrenia Screening, Prevention and Management

Schizophrenia is a rare mental health condition and the factors involved in its progression are unclear, making it difficult to screen for and prevent. There appears to be a genetic link, as the condition often tends to run in families, but it also depends on certain features of the brain and environmental circumstances.

Screening

Screening for schizophrenia is difficult because there are no reliable markers to indicate the subsequent development of the condition. Additionally, it is relatively rare, making it difficult for screening initiatives to offer cost-effective benefits to the general population that justify the means used to run the program.

There have been some public health campaigns that aimed to educate the general public about schizophrenia, specific risk factors and the early symptoms of the disease. These initiatives were intended to help detect individuals with the condition earlier and intervene with treatment as soon as possible. However, the relative efficacy and effect of these campaigns, when considering their costs, has not been clearly established.

Prevention

Similarly to the screening for schizophrenia, prevention of the disease poses a challenge because we are not able to accurately determine which individuals are most likely to be affected.

Substance abuse is strongly linked to schizophrenia with regular drug users more likely to suffer from the condition and a high percentage of schizophrenic patients have a history of drug abuse. For this reason, the avoidance of drugs such as cannabis, cocaine and amphetamines is recommended in the prevention of schizophrenia.

Social support is also very important for individuals to manage stressful life events and prevent triggers for the initiation of schizophrenia from occurring. Where possible, people at risk should have a network they can trust to talk through any issues with and avoid isolation.

Early Intervention

There is some scientific evidence to support the use of early interventions to prevent the progression of an at-risk individual into suffering from schizophrenia. It is proposed that these interventions help to improve short-term outcomes, although the overall benefit over time is not clear.

Individuals that are most likely to benefit include those that have experience a single psychotic episode. Cognitive behavior therapy may help to reduce the risk of a subsequent episode and help patients prevent the progression to schizophrenia.

Management

There are a number of management techniques that may be recommended for patients with the condition.

Pharmacotherapy with antipsychotic drugs, such as risperidone or olanzapine, is almost always suggested to help patients to manage the symptoms. They offer an effective solution to reduce symptoms, particularly the positive symptoms such as hallucinations and delusions. They are less effective in the treatment of negative symptoms, such as disorganized thinking and behaviour.

In addition, psychotherapy is a very helpful tool in the management of schizophrenia. There are various different types of therapy, which may be delivered on an individual basis with the therapist, in a group situation or inclusive of family members and people that care for the patient with schizophrenia.

Psychotherapy is important as it enables patients to work through any issues or concerns they may have and address stressful situations before they develop into a psychotic episode.

References

  • http://www.ncbi.nlm.nih.gov/pubmed/16060596
  • http://aaswsw.org/wp-content/uploads/2013/10/Prevention-of-Schizophrenia-and-Severe-Mental-Illness-3.24.15.pdf
  • http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml#part_145429
  • http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3190243/

Further Reading

  • All Schizophrenia Content
  • Schizophrenia
  • Schizophrenia Diagnosis
  • Schizophrenia Causes
  • Schizophrenia Signs and Symptoms
More…

Last Updated: Aug 23, 2018

Written by

Susan Chow

Susan holds a Ph.D in cell and molecular biology from Dartmouth College in the United States and is also a certified editor in the life sciences (ELS). She worked in a diabetes research lab for many years before becoming a medical and scientific writer. Susan loves to write about all aspects of science and medicine but is particularly passionate about sharing advances in cancer therapies. Outside of work, Susan enjoys reading, spending time at the lake, and watching her sons play sports.

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Dengue Fever Epidemic

Dengue fever is a common viral infection in tropical and subtropical regions that is carried and spread by mosquitoes. There has been a dramatic resurgence of epidemic dengue in the tropics worldwide. In particular, the emergence of a life-threatening complication of the illness called dengue haemorrhagic fever is a major public health concern.

There are several factors that have been identified as causing this resurgence of dengue fever and these include:

  • Major global demographic changes have resulted in uncontrolled urbanization and population growth in some regions. This has led to a relative shortage of good quality housing that results in poor sanitation and inadequate sewer and waste management systems. The mosquito that carries the dengue virus breeds in the walls of water containers and inadequate maintenance of fresh water supplies in urbanized and overcrowded areas leads to increases in these mosquito populations.
  • Financial difficulties and lack of human resources make it difficult to implement emergency control methods in response to dengue epidemics to prevent spread.
  • In the continental United States, dengue fever is rare and the surveillance of the infection is passive, with cases of infection only being detected if a doctor reports it.
  • Air travel to countries where the infection is epidemic helps to transport the infection between countries. People can pick up an infection while staying in the tropics and then transmit it to people in areas where the infection is less common.
  • In endemic regions, there is usually a severe lack of effective mosquito control, which has also contributed to the spread of the infection.

Dengue fever has been recognized as a threat to public health by the National Institute of Allergy and Infectious diseases (NIAID), which funds over 60 dengue research projects to study the life threatening complications of the illness – dengue haemorrhagic fever and dengue shock syndrome. The body also funds research into the development of vaccines against the virus.

Sources

  • http://www.nhs.uk/Conditions/dengue/Pages/Introduction.aspx
  • health.nt.gov.au/…/…&siteID=1&str_title=Dengue%20Fever.pdf
  • photos.state.gov/libraries/bahamas/5/consularacs/denguefever.pdf
  • http://www.cdc.gov/dengue/clinicalLab/
  • www.nea.gov.sg/…/…0the%20prevention%20of%20mosquito%20breeding.pdf
  • www.cdph.ca.gov/…/DengueInfoForHealthCarePractitioners.pdf

Further Reading

  • All Dengue Fever Content
  • Dengue Fever
  • Dengue Fever Symptoms
  • Dengue Fever Treatment
  • Dengue Fever Transmission
More…

Last Updated: Feb 26, 2019

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

Source: Read Full Article

Bipolar Disorder Counseling

Treatments for bipolar disorder include medication and psychotherapy or counselling. Using a combination of these approaches may help reduce the dose of medication required to stabilize a patient's mood swings.

Some of the benefits of counselling or "talking therapy" for people with bipolar disorder include:

  • Guidance in coping with symptoms and identifying extreme mood changes and when to seek help
  • Advice about how to cope with suicidal thoughts
  • Education about bipolar disorder and living with the condition
  • Support for individuals who have the condition as well as for their families

Who provides counselling?

Counselling is typically provided by a psychologist, counsellor or a social worker and is usually prescribed by a patient's doctor. The frequency, duration and number of sessions a patient receives is determined according to their individual needs.

Types of counselling

Some of the methods used in counselling people with bipolar disorder include:

  • Cognitive behavioural therap is one of the most well known approaches and is used to help patients learn to change any negative thoughts patterns that lead to behaviour that may be harmful to them.
  • Family-focused therapy helps the family of a patient with bipolar disorder to identify, cope with and solve problems arising from living with the condition, as well as helping to improve communication between family members.
  • Individuals with bipolar disorder may also be given assistance in improving their interpersonal relationships and regulating their social rhythms. This can help patientsto re-establish themselves in society and maintain regular daily routines and sleep patterns that may help prevent the onset of manic episodes.
  • Psychoeducation is another approach offered which helps bipolar disorder patients learn about their condition and how to recognize signs of relapse so they can seek treatment prior to the onset of a manic episode. Psychoeducation is also a helpful tool for family members and carers of people with bipolar disorder.

Sources

  1. http://www.nhs.uk/Conditions/Bipolar-disorder/Pages/Introduction.aspx
  2. www.nimh.nih.gov/…/nimh-bipolar-adults.pdf
  3. www.nami.org/…/ContentDisplay.cfm&ContentID=67728
  4. http://brfa.avenue.org/BADFactSheet.pdf
  5. www.mentalhealthscreening.org/…/nimh%20Bipolar%20(brochure).pdf

Further Reading

  • All Bipolar Disorder Content
  • Bipolar Disorder
  • Bipolar Disorder Symptoms
  • Bipolar Disorder Diagnosis
  • Bipolar Disorder Treatment
More…

Last Updated: Feb 26, 2019

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

Source: Read Full Article

Barth Syndrome

Barth syndrome is a rare, genetic disorder that affects males. The condition is caused by mutations in the tafazzin gene, which codes for an enzyme involved in the synthesis of cardiolipin, an important lipid component of the inner mitochondrial membrane. The condition affects energy production in the mitochondria and leads to complications such as cardiomyopathy, muscle weakness and neutropenia.

Symptoms

Symptoms are not always present but some typical features of Barth syndrome include:

Cardiomyopathy – Cardiomyopathy describes a deterioration in the myocardium or heart muscle. The muscle is usually dilated or stretched with a varying degree of hypertrophy (increase in size).

Neutropenia – This refers to an abnormally low number of neutrophils (a type of white blood cell) in the blood.

Skeletal muscle development may be abnormal and muscle tone weak.

Levels of organic acids in the blood and urine may be increased. Levels of 3-methylglutaconic acid, for example, are typically raised by 5 to 20-fold.

Delayed growth during pre-teen years with growth often accelerated later on, in adolescence.

Cardiolipin abnormality

Complications of Barth's syndrome

Barth's syndrome may cause a range of complications some of which are listed below:

  • Cardiomyopathy increases the likelihood of a dangerous abnormal heart rhythm or arrhythmia which can be fatal.
  • Neutropenia increases the likelihood of infection, particularly of the mucous membranes such as the skin or inside of the mouth. A fever may also be present.
  • Diarrhea and/or constipation.
  • Weak muscle tone may lead to fatigue and difficulty exercising.
  • Affected individuals may have feeding problems such as difficulty in sucking, swallowing or chewing, an aversion to some foods and be selective or fussy eaters.
  • The risk of thrombosis or blood clots is increased.
  • There is a risk of hypoglycemia or low blood sugar, especially when a child is newborn.
  • Chronic (long-term) headache, abdominal pain, and/or body aches, particularly, during puberty.
  • Mild learning disabilities may develop.
  • The risk for osteoporosis is increased.

Phases of Barth syndrome

General phases of the disease are often but not always seen in children with the syndrome and these include:

  1. Children often become seriously ill before the age of 5
  2. Between ages 5 to 11, symptoms typically improve and patients tend to be free of symptoms
  3. Adolescence often marks the return of symptoms

Treatment and management

There is no cure for Barth's syndrome and treatment is focused on managing the condition. Usually, the treatment approach to Barth's syndrome involves a team of specialists including experts in biochemistry, genetics and neurology as well as nurses, social workers, nutritionists and physical and occupational therapists.

Barth syndrome is suspected if a person presents with one of the main characteristics of the disease or if there is a family history of the condition. Diagnosis involves DNA sequencing to detect the tafazzin gene (TAZ, also called G4.5) mutation and analysis of cardiolipin in various cells and tissues.

Genetics

This is an X-linked inherited genetic disease, so a mother may be a carrier of the mutated gene despite not having any symptoms. There is a 50% chance that a boy born to a carrier mother will have the condition and a 50% chance that any daughters she has will be carriers themselves. All daughters of a male with the condition will be carriers but no sons will be affected.

Sources

  1. www.barthsyndrome.org/…/…re_BSF_June2011_web37PEL-6282011-6122.pdf
  2. https://www.orpha.net/data/patho/Pro/en/Barth-FRenPro1059.pdf
  3. http://www.childrenshospital.org/az/Site1404/mainpageS1404P1.html
  4. www.barthsyndrome.org/…/…eFAQs_FINAL_May200637WDF-5292006-9233.pdf

Further Reading

  • All Barth Syndrome Content

Last Updated: Feb 26, 2019

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

Source: Read Full Article