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Evalytics 18 April at 01.38 PM

Diversity in Clinical Trials: Why One Size Does Not Fit All


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What you need to know

The abortion pill legal battle will be heading toward a Supreme Court finale. Seeking a reversal of mifepristone restrictions via Supreme Court review, the Biden administration would need to win the votes of at least five of the nine justices on the Supreme Court, which has a 6-3 conservative majority.
E-cigarette maker Juul Labs Inc has agreed to pay out $462 million to settle claims made across six U.S. states regarding unlawfully marketing its addictive products to minors. While Juul has not admitted wrongdoing in the settlement, their settlement contributions now total more than $1 billion across 45 states.
Over 2.5 million cases of sexually transmitted infections were reported in 2021, which indicates a 7% increase in one year, according to the U.S. Centers for Disease Control and Prevention. Chlamydia, accounting for above half of those reported cases, saw a 4% rise in 2021, and gonorrhea jumped almost 5% as well.
The U.S. Environmental Protection Agency recently proposed an updated list of restrictions on facilities utilizing the cancer-causing chemical ethylene oxide, most used in sterilizing medical devices and spices. The EPA aims to reduce the released ethylene oxide gas from facilities and plants by 80%, meeting a new Clear Air Act standard for emission levels.
The Environmental Protection Agency has detected particulate matter in the smoke surrounding the air of Richmond, Indiana following a plastics fire. This finding raises fears that cancer-causing toxins could be spreading throughout the area, and potentially include asbestos.

Opinion

Henry Engel, victim of Rett Syndrome, donates his cells to create a legacy in innovative research for a cure.
Henry Engel, the late son of NBC News chief foreign correspondent Richard Engel, passed away nearly 8 months ago at the age of 6 to the neurological disorder Rett Syndrome. Beyond the grave, Henry and his surviving cells are still a focal point of research aimed at preventing other children from losing their lives to Rett syndrome.
  • Henry Engel was found to have a unique mutation attributed to his development of Rett syndrome. The symptoms of Rett syndrome involve severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat, and even breathe easily.

  • MECP2 is found on the X chromosome, which females have two of, so it’s even rarer and more severe in males because they only have one X chromosome.

  • Henry’s mutation affected the function of the MECP2 gene in such a way that it caused an important protein for brain development to be produced at lower levels.
Henry’s physician, Dr. Huda Zoghbi, states: “Our Rett syndrome research will continue to push as hard as possible to develop treatments. This is how we will honor Henry’s life. Studying [Henry’s] cells helped us to think a little differently, to find yet one more approach for developing therapies for Rett,” she said. “If we’re successful, that can help so many patients. That would be a dream. That would be [Henry’s] legacy.”


Enter evalytics labs

Diversity in Clinical Trials: Why One Size Does Not Fit All
Clinical trials are a critical part of medical research, as they help determine the safety and efficacy of new treatments and therapies. However, a lack of diversity in clinical trials can have significant consequences, from bias in study results to inadequate representation of certain populations. In this blog post, we will explore why diversity in clinical trials is important, the potential consequences of a lack of diversity, and the ongoing efforts to enhance diversity in clinical trials.
Gain valuable insights about different Clinical Trials and more at http://npilookup.evalyticslabs.com.

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What to Watch For

Drug Czar Declares Tranq as an Emerging Threat in the United States
President Joe Biden’s drug czar has declared tranq, a deadly combination of fentanyl mixed with xylazine, as an emerging threat facing the nation after being linked to a staggering rise in overdose deaths in the United States. Dr. Rahul Gupta, the director of the Office of National Drug Control and Policy, demands a federal plan from the Biden administration to address the crisis.
Key takeaways
  • Xylazine is not approved for human use, and ingesting it can cause serious, life-threatening effects. People who inject it can develop flesh wounds, including blackened, rotting tissue (known as necrosis); if untreated, those injuries may result in amputation.

  • Gupta said the federal government would be mindful that xylazine has “legitimate” uses in the veterinary profession and the agriculture industry while it works on a whole of government response that includes evidence-based prevention, treatment and supply reduction.

  • Xylazine is regarded by the DEA as the deadliest drug our country has ever faced, mainly because xylazine is not an opioid, overdoses cannot be reversed by the opioid overdose antidote naloxone, better known as Narcan.
By the digits
  • 90 days for the Biden administration to coordinate a national response.

  • 12-day deadline to send implementation guidance to agencies.

  • 23% of fentanyl powder and 7% of fentanyl pills contained Xylazine.

  • 66% of the 107,735 deaths from August 2021 to August 2021 from drug poisonings involved synthetic opioids such as fentanyl.

  • 2020-2021 Xylazine-linked deaths increased more than 1,000% in the South, 750% in the West and more than 500% in the Midwest according to the DEA.

Challenge Yourself

Is There a Doctor in the House?
Take our weekly quiz and see how you stack up against your peers
A 12-year-old girl is brought to the emergency department by her mother because of a 1-week history of worsening swelling in her legs. The patient also noticed blood in her urine yesterday. The bleeding has not recurred. She had an upper respiratory tract infection and sore throat 1 week ago that caused her to miss several days of school. Medical history is otherwise unremarkable, and she takes no routine medications. Menarche has not yet occurred. BMI is 20 kg/m2. Vital signs are temperature 37.0°C (98.6°F), pulse 78/min, respirations 12/min, and blood pressure 136/84 mm Hg. Pulse oximetry on room air shows an oxygen saturation of 100%. Physical examination discloses erythema of the posterior pharynx, mild cervical lymphadenopathy, and 3+ pitting edema to both knees. Results of urinalysis are shown:

Protein 150 mg/dL
Blood Positive
Leukocyte esterase Positive
Nitrite Negative WBCs 5−10/hpf
RBCs 10−25/hpf
Casts 1−2/lpf

Results of which of the following laboratory studies are most likely to be abnormal in this patient?
A  Bleeding time
B  Erythrocyte count
C  Serum concentration of C3
D  Serum IgA concentration


SURPRISING DISCOVERIES

New lab tests that can detect traces of a key protein that misfolds and gums up specific areas of the brain, called alpha-synuclein, may offer accelerated Parkinson’s diagnosis. Doctors currently diagnose the progressive condition by looking for telltale physical symptoms: tremors, a halting gait, stiffness or trouble balancing.
Hearing loss found to increase the risk for dementia, but using hearing aids lower that risk and normalize in comparison to those without hearing loss. The study also found that not enough adults use hearing aids, only 15% who experience hearing loss in fact.
Nearly 1 in 5 adults has had a family member killed by a gun, including in homicide and suicide, new survey finds. About as many adults have been personally threatened with a gun, and about 1 in 6 adults has witnessed an injury from a shooting, the survey found.
Almost 90% of mpox-related deaths in the United States were among Black men, and nearly all had weakened immune systems, according to a new report from the U.S. CDC. Most people hospitalized for severe cases of mpox were Black men with uncontrolled HIV that may have caused a weakened immune system, according to the report.


Thank you for reading! More next week,
My best wishes for a productive and idea-filled week ahead. Thanks for your ongoing efforts to improve the lives of the patients we all serve. Please send any news, comments, suggestions and ideas to hello@morningmed.email.
Quiz answer: The correct answer is C) "Serum concentration of C3"

 

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