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Month: June 2018

Pembrolizumab Secures FDA Approval in Stomach Cancer

October 12, 2017, by NCI Staff

An FDG-PET scan of a patient with gastroesophageal junction cancer.
Credit: Li M, Oxford Medical Case Reports Sept. 2014. doi: 10.1093/omcr/omu041.

The Food & Drug Administration (FDA) has granted accelerated approval to the immunotherapy drug pembrolizumab (Keytruda®) for use in some patients with advanced gastric (stomach) cancer.
The approval, announced on September 22, covers the use of pembrolizumab in patients with advanced gastric cancer or gastroesophageal junction cancer that has progressed despite two or more prior lines of treatment with standard therapies. The gastroesophageal junction is a narrow space where the esophagus meets the stomach.
To receive the drug, patients’ tumors also must express the protein PD-L1. In conjunction with the pembrolizumab approval, FDA also cleared the Dako PD-L1 IHC 22C3 pharmDx assay to measure PD-L1 expression in patients with gastric cancer.
As is often the case with accelerated approvals, FDA based its decision on promising results from an early- or mid-stage clinical trial. In this case, the approval was based on findings from a stage 2 clinical trial, called Keynote-059, in which all patients, regardless of PD-L1 status, received pembrolizumab.
In the trial, which enrolled 259 patients with advanced gastric or gastroesophageal junction cancer, approximately 12% of patients experienced at least partial tumor shrinkage following treatment. However, patients in the trial whose tumors expressed PD-L1 (I’m.e., were PD-L1 positive) were more likely to respond.
According to the most recent data from the trial, presented last month at the European Society for Medical Oncology (ESMO) annual meeting, 16% of PD-L1-positive patients achieved at…

Incidence of Cancers of the Lower Stomach Increasing among Younger Americans

January 18, 2018, by NCI Staff

The incidence of noncardia gastric cancers—those occurring in the lower part of the stomach—has been increasing for Americans under age 50.
Credit: National Cancer Institute

A type of cancer that occurs in the lower stomach has been increasing among some Americans under the age of 50, even though in the general population the incidence of all stomach cancers has been declining for decades, according to a new NCI-led study.
The study tracked the incidence in the United States of cancer of the lower stomach, known as noncardia gastric cancer.
Between 1995 & 2003, the incidence of noncardia gastric cancer in the general population declined by about 2.3% per year, researchers reported January 18 in the Journal of the National Cancer Institute. But when they analyzed the data by birth year, they identified two distinct trends.
Among Americans over age 50, incidence rates fell by 2.6% per year; for those under age 50, however, the rates increased 1.3% per year.
“These results were surprising,” said M. Constanza Camargo, Ph.D., of NCI’s Division of Cancer Epidemiology & Genetics, who led the study. The general decrease in incidence rates for noncardia gastric cancer initially masked the divergence between older and younger individuals, she added.
Risk Factors & Shifting Incidence Rates
Two of the main causes of noncardia gastric cancer are infection by the bacterium Helicobacter pylori & autoimmune gastritis, which occurs when a person’s immune system attacks the lining of the stomach.
The prevalence of H. pylori infection has clearly decreased in the United States over the past…

June 5, 2018: Opioid Prescription Conspiracy Leader Pleads Guilty


  Food & Drug Administration Office of Criminal Investigations  

PROVIDENCE, RI – A Providence man who led a conspiracy to create fraudulent prescriptions for opioid pills using stolen medical practitioner identification numbers and identities, and, at times, unlawfully paying for the prescriptions with the use of medical insurance, has pleaded guilty in U.S. District Court in Providence to conspiracy to distribute and possess with the intent to distribute Oxycodone, & aggravated identity theft.
Robert Rose, 52, the acknowledged leader of the conspiracy, is the fourth person to plead guilty for their role in the conspiracy, announced United States Attorney Stephen G. Dambruch & Jeffrey Ebersole Resident Agent in Charge of the United States Food & Drug Administration Office of Criminal Investigations.
A fifth defendant charged in this matter is awaiting trial in U.S. District Court.
According to court documents, it was the intent of the conspiracy to manufacture fraudulent prescriptions utilizing the identities & Drug Enforcement Administration (DEA) identification numbers and signatures of medical practitioners without their consent. Prescriptions for varying amounts of Oxycodone pills were written & presented to pharmacies by some members of the conspiracy & others working at the direction of the conspirators. The scheme often times included the fraudulent use of medical insurance to pay pharmacies for the illicit prescriptions. Most of the Oxycodone pills gained with the use of fraudulent prescriptions were sold to other people for distribution.
At the time of his guilty plea, Robert Rose admitted to the Court that as the leader of the conspiracy, he…

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella. Use or consumption of products contaminated with Salmonella may result in serious illness. It can also produce serious & sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy individuals infected with Salmonella can experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream & producing more severe illnesses such as arterial infections (I.e., infected aneurysms), endocarditis & arthritis.
Reports of illnesses linked to these products are under investigation, & Caito Foods is voluntarily recalling the products out of an abundance of caution. The company has been advised by the CDC that it has linked 58 illnesses to the strain of Salmonella under inquiry. Caito Foods has ceased producing & distributing these products as the company & FDA continue their inquiry.
The products were packaged in clear, plastic clamshell containers and distributed in Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina & Ohio.
Because it is possible that products shipped between April 17 & June 7, 2018 could still be on store shelves, this recall extends to both retailers & consumers.
The potential that these products are contaminated with Salmonella was discovered through analyzing reports made by state departments of public health. Caito Foods…

NLM Technical Bulletin, May-Jun 2018, NCBI Minute Webinar: Using EDirect to Access a Local Installation of PubMed on June 13, 2018

NCBI Minute Webinar: Using EDirect to Access a Local Installation of PubMed on June 13, 2018. NLM Tech Bull. 2018 May-Jun;(422):b8.
2018 June 08 [posted]
On Wednesday, June 13, 2018, join National Center for Biotechnology Information (NCBI) staff for a Webinar on how to use EDirect to install PubMed locally and then retrieve & process records from the local instance. You will also see an example that shows the significant speed improvement with the EDirect local data cache & uses advanced EDirect xtract options to aid with processing records.
Date & time: Wednesday, June 13, 2018, 12:00 PM—12:30 PM EDT
Register here: https://bit.ly/2sPUKU3
After registering, you will receive a confirmation email with information about attending the Webinar. After the live presentation, the Webinar will be uploaded to the NCBI YouTube channel. You can learn about future Webinars on the Webinars & Courses page. …

NLM Fun at the STEM Festival

NIH was a major presence at the Health & Medicine section at the fifth USA Science & Engineering Festival this spring.

It was STEM on a grand scale as NLM took part in activities at the NIH pavilion of the Health & Medicine section at the fifth USA Science & Engineering Festival (USASEF) this spring. Families filled the NIH pavilion, where they could engage in more than 30 hands-on activities focusing on health, biomedical, & behavioral science topics. Laughter, gasps of surprise, & lots of enthusiasm were in the air on the part of parents, family members, & teachers.
The nation’s largest biennial celebration of science, technology, engineering and math (STEM), this year’s event attracted a record-breaking crowd of more than 370,000 people as enthusiasts of all ages explored the mysteries & delights of STEM at the Convention Center in Washington, DC.
Fun and games—plus serious knowledge—at the NLM booth
Enthusiastic NLM volunteers (from left): Melanie Modlin, Elena Leon, Shannon Sheridan, Linda Smith (holding Toxie the cat, mascot of the “Toxic Toss” game), & Maria Fleitas.

As children tossed beanbags in game that NLM called “Toxic Toss,” NLM volunteers from across the Library taught them about common hazardous substances & the potential risk to human health when they’re not handled properly.
Children also were invited to color images from NLM’s popular online exhibition, Harry Potter’s World: Renaissance Science, Magic, and Medicine, & pictures of DNA & gene structures. This was a way to highlight items from NLM’s collection. As the world’s largest medical library, NLM has…

Google Doodle Celebrates Birthday of Dr. Virginia Apgar & We Do, Too!

Google Doodle, June 7, 2018

Have you Googled today?
Today, June 7, Google Doodle celebrates Dr. Virginia Apgar (1909-1974) on what would be her 109th birthday, & we’re thrilled!
Dr. Apgar was a pioneering physician in the field of maternal health.
She developed a test that babies all over the worldwide are given at birth to quickly determine their health and viability.
After she developed this test, it became known as the APGAR score—A for Appearance, P for Pulse, G for Grimace, A for Activity and R for Respiration—with many not knowing that Apgar was not just an acronym but a real person.
As part of NLM’s Profiles in Science project, the Library collaborated with the Mount Holyoke College Archives & Special Collections to digitize and make available many of her papers. Dr. Apgar was also featured in the NLM exhibition Changing the Face of Medicine, which explored how women have influenced & enhanced the practice of medicine.
Read more about women in medical history.

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Prevent Heartworms in Dogs, Cats, & Ferrets Year-Round

 Subscribe: FDA Consumer Health Information
The bad news: Heartworm disease can be fatal to dogs, cats, & ferrets. The good news: You can protect your pet from this disease.
“It’s a preventable disease, which is why it’s so frustrating as a practitioner when you see a case,” says Melanie McLean, D.V.M., a veterinarian at the U.S. Food & Drug Administration (FDA). Treatment can be hard on animals, & McLean says it’s much easier & healthier for the pet to prevent the disease in the first place.
Heartworms are carried by infected mosquitoes that transmit parasitic worms that grow in the arteries of the lungs & heart of dogs, cats, & other species of mammals, including ferrets. The heartworm larvae enter the bite wound & move through the pet’s body. They can grow up to 12 inches long.
The disease is not contagious from one pet to another, & heartworms in humans are very rare.
Use Heartworm Prevention Medication Year-Round
The FDA has approved several heartworm prevention medications for dogs & cats, but only one, to date, for ferrets. Treatment can vary, as oral, injectable or topical, depending on the animal species, but they all target heartworm larvae, not adults.
That’s one reason veterinarians often recommend that pets receive heartworm prevention medication all year long. Although there are a fewer number of mosquitoes in the winter, there is still a risk that an animal could contract heartworms if the owner stops giving medication during this season.
“You never know when the first mosquito is going to come out,…

Eosinophilic Esophagitis May be Due to Missing Protein

Media Advisory
Wednesday, June 6, 2018 NIH-funded study finds replacement therapy reversed effects in tissue experiments. What
Scientists have discovered that the absence of a specific protein in cells lining the esophagus may cause inflammation & tissue damage in people with eosinophilic esophagitis (EoE).  EoE affects as many as 150,000 people in the United States, many of whom are children. People with EoE experience difficult or painful swallowing, vomiting and nutritional problems because an accumulation of immune cells called eosinophils scars the esophagus.
The researchers found that the protein, SPINK7, was nearly absent in esophageal biopsies taken from adults & children with active EoE but was prevalent in biopsies from healthy people. In a healthy esophagus, SPINK7 tamps down inflammation and helps preserve tissue structure.
Encouragingly, a licensed drug for emphysema reversed damaging inflammation in tissues lacking SPINK7, the investigators report in a paper posted online today in Science Translational Medicine. The researchers received support from the National Institute of Allergy and Infectious Diseases & the National Institute of Diabetes & Digestive & Kidney Diseases, both parts of the National Institutes of Health.
Because food contains enzymes that can damage human tissue, the lining of the esophagus normally protects itself by producing its own enzymes that degrade the offending proteins & thus protect the lining. Researchers led by Marc E. Rothenberg, M.D., Ph.D., at Cincinnati Children’s found that SPINK7 facilitates this protective process. When they silenced SPINK7, the gene that codes for SPINK7, in cells derived from esophageal tissues, the research team discovered that large…

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