Immune Research: Immune cells make appendix 'silent hero' of digestive health ♦ A molecular switch to stop inflammation ♦ Alerting the immune system's watchmen to improve vaccines

Immune cells make appendix 'silent hero' of digestive health Innate lymphoid cells (ILCs) are crucial for protecting against bacterial infection in people with compromised immune systems, report investigators.A network of immune cells helps the appendix to play a pivotal role in maintaining health of the digestive system, supporting the theory that the appendix isn't redundant

Neutrophils starve fungal invaders The most frequent immune cells in the human blood, so-called neutrophils, efficiently kill invading microorganisms and slowly starve microbes to death by removing crucial trace elements.

A molecular switch to stop inflammation Our immune system is vital to us and can sometimes overreact causing chronic illnesses, such as for instance rheumatism and allergy. Now, researchers have identified a molecular switch – MYSM1 – that can suppress such an overreaction and avoid inflammation

Alerting the immune system's watchmen to improve inflammation As the days get colder and shorter, we carve jack-o-lanterns and drink pumpkin spice lattes. But one fall tradition can actually keep you healthy: getting your flu shot. Like all vaccines, the flu shot trains the immune system to fend off infection, but some need help to produce the full effect. Researchers now report a new way to help improve vaccines using molecules that more effectively direct the immune system

Health News: Regenerative nanomaterials to improve dental care ♦ Report raises concern over health risks of tasers ♦ Fungal pathogen in GI tract

Coconut oil can control overgrowth of a fungal pathogen in GI tract, Coconut oil controlled the overgrowth of a fungal pathogen called Candida albicans (C. albicans) in mice, new research shows. In humans, high levels of C. albicans in the gastrointestinal tract can lead to bloodstream infections, including invasive candidiasis. The research suggests that it might be possible to use dietary approaches as an alternative to antifungal drugs in order to decrease the risk of infections caused by C. albicans

Regenerative nanomaterials to improve dental care New nanomaterials for dental treatments boast impressive antibacterial, decay-resistant and biomimetic properties. In combination with stem cells, they are even capable of regenerating dental tissues.

Combating sleep disorders: Scientists develop novel compound that regulates wakefulness potent compound that promotes wakefulness and remedies the sleep disorder narcolepsy in model animals has been developed by a team of scientists. The compound works to mimic the action of a wake-promoting substance in our brain called "orexin.

Report raises concern over health risks of tasers Tasers are increasingly being used by UK police, yet recent studies suggest the health risks are greater than previously thought, report experts. Tasers are used by over 16,000 police forces in 107 countries. The device uses compressed nitrogen to fire two barbed electrical probes that deliver a pulsed 50,000 volt shock, causing intense skeletal muscle contractions and pain.

NIH produces product with fungal contamination

NIH suspends operations in its Clinical Center Pharmaceutical Development Section

June 7, 2015

Correction: On June 4, NIH stated that operations at the Pharmaceutical Development Section (PDS) at the NIH Clinical Center had been suspended. All production of sterile materials in the PDS has indeed been suspended. However, production of other materials, which were not the focus of concern and do not require sterile manufacturing practices, will continue.

The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. Upon receipt of a complaint, Food and Drug Administration (FDA) representatives inspected the PDS between May 19 and May 29, and found a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.

The facility makes products for certain clinical research studies conducted in the hospital and collaborating facilities. In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination. Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated. The six patients have been notified and are being followed closely for any signs of infection. At this time, none has developed signs of infection or illness.

“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, M.D., Ph.D. “The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”

Among the problems the FDA identified in their inspection were deficiencies in the physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures. Deficiencies of lesser significance were identified in the Clinical Center Pharmacy. The FDA inspection reports are available here: http://www.cc.nih.gov/phar/pdfs/483.pdf (PDF - 1.31KB).

The following steps are being taken immediately to protect patients:

1. Operations of The Pharmaceutical Development Section have been suspended and no products will be made or distributed until all problems are fully understood and corrected. Materials produced by the Section are being systematically tested for contamination.
2. Of the participants in the 46 studies that are potentially affected, approximately 250 are currently scheduled to receive products manufactured by the PDS. NIH has notified the individual principal scientists responsible for each of those protocols, and is in the process of notifying the participants in these protocols. The vast majority of these patients are not immediately due for treatment and NIH is working to secure alternative sources for the products.
3. An external group of experts in microbiology and sterile manufacturing practices will be appointed to conduct a thorough review, including an assessment of all standard operating procedures, policies, staffing, and training, and make recommendations to the NIH director on the corrective actions required.
4. In addition to the immediate steps NIH is taking, it will provide an interim corrective action plan to the FDA by Friday, June 19, 2015.

“Our first responsibility is the safety and care of our patients,” said Dr. Collins. “NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation.”