- FDA steps up oversight of cell therapies (biopharmadive.com)
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...
- Retail pharmacy responds to communities in south Texas (drugstorenews.com)NACDS Members Mobilize for Hurricane Harvey Recovery (nacds.org)
In response to the devastation associated with Hurricane Harvey, several retailers have stepped up their giving...H-E-B...early into the storm donated $100,000 toward Hurricane Harvey relief efforts and have begun accepting customer donations for the families and communities devastated by the storm...H-E-B has received numerous requests from customers about how they can help support victims and communities affected…In Victoria, Texas, Walgreens loaned the city a generator in order for them to help power their sewage facility and prevent from comprising the water supply of 70,000 residents with sewage backflow. "We proactively staged generators in the area and were able to quickly provide one to the city during this emergency,"...CVS Health and the CVS Health Foundation gave $200,000 in cash and in-kind product donations to organizations helping with relief efforts for those affected...The CVS Health Foundation has donated $50,000 each to the Greater Houston Community Foundation and the American Red Cross, as well as $25,000 to Salvation Army, to aid the greater Houston area in supporting local residents...Walmart and the Walmart Foundation have made a $1 million commitment to provide support for relief efforts through cash and product donations. As a part of this commitment, Walmart is working closely with organizations like the American Red Cross, Salvation Army and Convoy of Hope while coordinating efforts with elected officials and governmental entities to help meet the needs of those affected...
- Insurer’s mailing to customers made HIV status visible through envelope window (statnews.com)
Thousands of people with HIV received mailed letters from Aetna last month that may have disclosed their HIV status on the envelope...The letters, which Aetna said were sent to approximately 12,000 people, were meant to relay a change in pharmacy benefits. Text visible through a small window on the envelopes listed the patients’ names and suggested a change in how they would fill the prescription for their treatment for the virus...“People have been devastated. We’ve had a number of people tell us they had chosen not to disclose their HIV status to family members — but this is how their family members found out,” said Sally Friedman, legal director at Legal Action Center...Aetna is in the process of notifying both state and federal authorities about the breach, a company spokesman said. The mailing was sent July 28...Plans across the country suffer privacy breaches, as do providers. A 2009 law requires companies that are covered by federal health privacy laws, like plans, providers, and their vendors, to report data breaches that affect more than 500 individuals. That database showed some 30 such breaches in July alone, though the tool does not detail the kind of information that was disclosed. Some breaches involve Social Security numbers or service codes…
- Saint Mary’s to close Reno Women’s Health Center (rgj.com)
Saint Mary's will close its outpatient Women's Health Center next month and will "align" with unnamed community health providers who offer similar services…Employees of the women's health center at the hospital's main location on Arlington Avenue have been offered transfers to open positions elsewhere in the system...The center will close Oct. 13...The hospital's Family Birthing Center will remain open and will continue to offer lactation support and childbirth education...Our goal is to remain focused on the obligation we have to our patients to provide quality services that are affordable and accessible...Therefore, when the advancement of medical services goes beyond our available resources, we seek to find collaborative opportunities so patients have access to the highest level of care offered locally...
- Nevada has shortage of pediatricians (businesspress.vegas)
Clark County has just 317 of them (pediatric specialists and subspecialists), according to the state Medical Examiners Board. That’s about 4.5 pediatricians per a population of 100,000, far below the national average of 7 per 100,000, according to the health services research for the Office of Statewide Initiatives at the University of Nevada, Reno School of Medicine. The data ranked Nevada 47th in the country in its lack of pediatricians....Nevada isn’t the only state being impacted. Shortages are being felt across the country due to the largest overall physician shortage in our nation’s history...According to an Association of American Medical Colleges’ 2016 report, our nation is projected to have a shortage ranging between 61,700 and 94,700 physicians by 2025...Pediatric specialists and subspecialists are two significant areas affected by the shortage. Reasons for this deficit include one-third of current physicians are aging out of the profession, and the reduced number of medical students entering pediatric specialties...Nevada...averages below the national trend with a larger deficit of pediatric specialists and subspecialists...“We’re basically treading water,” said Tabor Griswold...Office of Statewide Initiatives at the University of Nevada...She estimates the area needs slightly under a 50 percent increase in pediatric specialists to meet the U.S. median...
- Libertarian billionaire Peter Thiel funds “unethical” offshore human test of herpes vaccine, skirting FDA rules (salon.com)St. Kitts Launches Probe Of Herpes Vaccine Tests On U.S. Patients (khn.org)
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...
- People are using anti-diarrhea drugs to get high, and it’s becoming a serious problem (pulse.ng)
...People are using anti-diarrhea drugs (loperamide) to get high, and it’s becoming a serious problem...A growing number of people are using high doses of it to mimic an opioid-like high, or to manage opioid withdrawal symptoms...So why would anyone take 150 tablets of anti-diarrhea drugs in the first place?...Abuse of loperamide—often called the “poor man’s methadone”—is rising. From 2010 to 2015, there has been a 91 percent increase in loperamide overdose exposures reported to the National Poison Data System...when you take it in much-higher-than-recommended dosages, the drug can enter into your central nervous system, giving you a euphoric high. High doses can also cause constipation, but no worse than other opioids...taking too much of it can have deadly consequences, too: Research has shown that loperamide overdose can seriously hurt your heart, causing abnormal heart beat, rapid heart beat, or cardiac arrest...
- Big-name tech investors pour millions into marijuana — both medicinal and not (statnews.com)
The storied Silicon Valley venture firm Benchmark Capital has launched a slew of tech companies: Twitter, Uber, Snapchat, Instagram. Now its search for the next big thing has led it to…pot...Benchmark recently invested $8 million in Hound Labs, a startup here in Oakland that’s developing a device for drivers — and law enforcement — to test whether they’re too buzzed to take the wheel...Wealthy investors are pouring tens of millions into the cannabis industry in a bid to capitalize on the gold rush that’s expected when California legalizes recreational marijuana on Jan. 1. They’re backing development of new medicinal products, such as cannabis-infused skin patches; new methods for vaporizing and inhaling; and “budtender” apps like PotBot, which promises to scour 750 strains of cannabis and use lab research, including DNA analysis of each strain, to help customers find the perfect match...Among the noted investors: tech and biotech mogul Peter Thiel, who co-founded PayPal and made a fortune with the cancer drug startup Stemcentrx. Thiel contributed $300,000 to the California ballot campaign that paved the way for legalization. And in the first public endorsement of the industry from a major biotech investor, Thiel’s Founders Fund has sent millions to Privateer Holdings, a Seattle private equity firm that backs research into medical marijuana products, among other cannabis-related ventures...
- J&J ordered to pay $417 million in trial over talc cancer risks (reuters.com)
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...
- Micro-hospitals moving into the Las Vegas Valley (reviewjournal.com)
A new type of medical facility is popping up in Las Vegas neighborhoods: a combination of a hospital, a place to get specialty care and an urgent care center...It’s called a micro-hospital or a neighborhood hospital...The model is so new that there isn’t much data available to measure their performance in other markets...several local experts are hopeful that micro-hospitals will improve Nevada’s health care system...Dignity Health and Emerus partnered to open three of these neighborhood hospitals in the valley so far this year, with another planned for December...the goal is to improve local access to emergency services and physicians...Microhospitals are able to come online much faster than a traditional hospital...micro-hospitals cost between $15 million and $20 million to build and equip and range between 20,000 and 60,000 square feet...a traditional hospital generally costs between $150 million and $250 million to build and equip and is typically about 74,600 square feet...Since a micro-hospital has inpatient beds and provides hospital services, operators may be able to charge hospital-based rates, allowing for higher reimbursement, despite having lower overhead costs than a hospital...