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As early as January 1, Oregon pharmacists will be permitted to prescribe and dispense drugs and devices listed on a formulary to be established by the state board of pharmacy under a bill recently signed by Governor Katherine Brown...The formulary, according to the new law, may contain such "post-diagnostic" items as diabetic testing supplies, smoking-cessation aids, epinephrine autoinjectors, albuterol inhalers, rapid strep tests, and spacers for inhalers...Other possibilities mentioned in the law are discharge medications during transitions of care and emergency refills of insulin..."Nothing about this is new territory," said Michael E. Millard, cochair of the Oregon Society of Health-System Pharmacists...Legal and Regulatory Affairs Committee, in explaining why the prescribing bill passed the legislature on the first try...the bill builds on past legislation and advances pharmacy practice a step further...

Nevada NewsMakers: Host: Sam Shad - Guest: Heather Korbulic, Executive Director of the Silver State Health Exchange

Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians...are backing the offshore testing of an experimental herpes vaccine...Peter Thiel, invested $7 million in the ongoing vaccine research...Southern Illinois University also trumpeted the research and the study’s lead researcher...Neither the Food and Drug Administration nor a safety panel known as an institutional review board..monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines...“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”...The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected...

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

FDA...announced the approval of tisagenlecleucel, a first-in-class chimeric antigen receptor (CAR) T-cell immunotherapy consisting of genetically modified autologous T cells, for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and young adults...After modification in the laboratory and infusion back into the patient, the CAR T cells target and eliminate both normal and malignant CD19-expressing B cells. The genetic modification enhances the initiation of T-cell activation and the persistence of the transformed T cells...Novartis will market tisagenlecleucel as Kymriah. Labeling for the product states that it is indicated in patients up to age 25 years with ALL that is refractory or in second or later relapse...Tisagenlecleucel has an FDA-required risk evaluation and mitigation strategy (REMS) program that includes elements to assure safe use. The labeling states that the immunotherapy is available "only through a restricted program."...

The Food and Drug Administration is stepping up its enforcement of the existing rules covering stem cell therapies in order to protect patients from unproven or potentially dangerous treatments...Under "a comprehensive policy framework" that will be put into place next quarter, individual providers and companies will be able to gain approval for products and procedures through a lower-cost and more streamlined process...A new working group will pursue unscrupulous clinics through legally enforceable means in order to protect public health...Patients desperately seeking solutions for potentially fatal diseases can get to a point that they will clutch at any solution offered...FDA Commissioner Scott Gottlieb's statement shows an awareness of the potential for "unscrupulous actors" in the field, and their impact both on vulnerable people and on the reputation of sound researchers and companies..."These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area," said Gottlieb...

A California jury...ordered Johnson & Johnson to pay $417 million to a woman who claimed she developed ovarian cancer after using the company's talc-based products like Johnson's Baby Powder for feminine hygiene...The Los Angeles Superior Court jury's verdict in favor of California resident Eva Echeverria was the largest yet in lawsuits alleging J&J failed to adequately warn consumers about the cancer risks of its talc-based products...The verdict included $70 million in compensatory damages and $347 million in punitive damages. It was a major setback for J&J, which faces 4,800 similar claims nationally and has been hit with over $300 million in verdicts by juries in Missouri...The 63-year-old claimed she developed terminal ovarian cancer after decades of using J&J's products. Her lawyers argued J&J encouraged women to use its products despite knowing of studies linking ovarian cancer to genital talc use...

A new nonprofit created by heavy hitters from Nevada’s business and medical communities gave the state a D grade on its first report card on the state’s health care system...The report card was released...by the Nevada Medical Center and is intended to focus attention on improving access to quality health care in the state...Larry Matheis, the NMC’s CEO, said the report card will help state leaders focus on the gaps that must be filled to improve Nevada’s medical standing. Currently, he said, the state’s medical system “resembles a series of isolated communities…due to the lack of collaboration among medical professionals and the dearth of thought given to enhancing our community’s reputation.”...The report card’s grades, based on analysis of data supplied by the Centers for Disease Control and Prevention and other government agencies, show how Nevada fares in the categories of health care access, chronic disease, nutrition and activity, mental health and substance abuse. The grades weren’t all bad, with the state receiving a passing “C” grade on chronic disease and a better-than-average “B” on nutrition and activity.

The US Food and Drug Administration has stopped a California company from continuing to inject the smallpox vaccine into the tumors of cancer patients...US marshals seized five vials of the smallpox vaccine from San Diego-based StemImmune Inc, which was using them as part of an unproven method for treating tumors...he vaccine is not commercially available and is only reserved for people who are at very high risk for developing smallpox, so it’s not clear how StemImmune got the vials to begin with. Luckily, the vaccine is not made from the actual smallpox virus and cannot give anyone the disease...It was...not meant to be used the way StemImmune was doing so, which was by mixing it with stem cells that come from body fat and injecting it into the tumors of patients at California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage...The FDA is encouraging consumers who have tried the treatment and had bad effects to use its MedWatch Adverse Event Reporting program.

The UNLV School of Medicine is breaking with traditional teaching methods when the school’s 60 medical students start their anatomy class in November...Instead of using cadavers for dissections of the human body, the school invested $600,000 in the use of virtual technology. Students will learn anatomy by using virtual anatomy tables with large, interactive touch screens that are large, super high-resolution computer screens. They cost $100,000 each...The school describes them as body images in a wide variety of perspectives. They are primed with a library of images, such as X-rays, MRIs, CT scans and pathology slides...Students will be able dissect, rotate, slice, and reassemble organs and other anatomic structures as needed. They will download case studies of real patients and examine them. They also can explore the histology and histopathology of the organ systems studied… UNLV will be the first allopathic medical school to use virtual 3-D anatomy...This is a very innovative way of doing this...No one else in the country has attempted to do what we’re doing. We’re cutting-edge at this point...