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Friday, March 17, 2023
Wednesday, March 8, 2023
Abbott's lab-based blood test for concussion scores FDA nod
The Eye-Sync platform from SyncThink uses AI to analyze the results of a series of fast-paced eye-tracking assessments, in tandem with standard neurocognitive tests, patient records and reported symptoms, to determine the type and severity of cognitive dysfunction caused by a head injury.
The technology previously received 510(k) clearance from the FDA in 2016 for use in detecting impairments in patients’ gaze and visual tracking abilities. The new clearance extends the platform’s indications, allowing healthcare providers in the U.S. to use it to help diagnose both concussion and mild traumatic brain injury.
The Eye-Sync platform from SyncThink uses AI to analyze the results of a series of fast-paced eye-tracking assessments, in tandem with standard neurocognitive tests, patient records and reported symptoms, to determine the type and severity of cognitive dysfunction caused by a head injury.
The technology previously received 510(k) clearance from the FDA in 2016 for use in detecting impairments in patients’ gaze and visual tracking abilities. The new clearance extends the platform’s indications, allowing healthcare providers in the U.S. to use it to help diagnose both concussion and mild traumatic brain injury.
SyncThink isn’t the only medtech developer attempting to clear the thorny pathway to concussion diagnosis.
BrainScope, for one, added an FDA-cleared, concussion-detecting algorithm of its own to its point-of-care brain-scanning headset in March. The Concussion Index analyzes multiple EEG readings from the headset to monitor the progression of traumatic injuries, hidden bleeds and concussions.
Abbott, too, has thrown its hat in the ring. In January, the FDA doled out yet another clearance for concussion detection, this time for Abbott’s i-STAT Alinity platform, a hand-held rapid blood-testing system that measures the amount of certain proteins in the bloodstream after a head injury to determine whether further testing is required.
Thursday, February 23, 2023
The Norfolk Southern train derailment in Ohio brought forth the real dangers of toxic chemical transportation via rail in the United States. The EPA and DOT have jurisdiction in these areas as guardians of public safety in transportation and environmental health.
Tuesday, February 14, 2023
Data brokers are now selling your mental health status - The Washington Post
Capitalizing on the pandemic explosion in telehealth and therapy apps that collect details of your mental health needs, data brokers are packaging that information for resale, a new study finds. There’s no law stopping them.
Telemedicine and HIPAA Compliance
The portions of HIPAA governing telemedicine are the Privacy Rule and the Security Rule. The HIPAA Privacy Rule sets standards to protect patient medical records or any personal health information (PHI) transmitted between health insurance companies, clinicians, testing facilities, or anywhere this data is shared.
Tuesday, February 7, 2023
Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients
Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients
NEW YORK — The fear started when a few patients saw their nurses and dietitians posting job searches on LinkedIn.
Word spread to Facebook groups, and patients started calling Coram CVS, a major U.S. supplier of the compounded IV nutrients on which they rely for survival. To their dismay, CVS Health confirmed the rumors on June 1: It was closing 36 of the 71 branches of its Coram home infusion business and laying off about 2,000 nurses, dietitians, pharmacists, and other employees.
Many of the patients left in the lurch have life-threatening digestive disorders that render them unable to eat or drink. They depend on parenteral nutrition, or PN — in which amino acids, sugars, fats, vitamins, and electrolytes are pumped, in most cases, through a specialized catheter directly into a large vein near the heart.
The day after CVS’ move, another big supplier, Optum Rx, announced its own consolidation. Suddenly, thousands would be without their highly complex, shortage-plagued, essential drugs and nutrients.
“With this kind of disruption, patients can’t get through on the phones. They panic,” said Cynthia Reddick, a senior nutritionist who was let go in the CVS restructuring.
“It was very difficult. Many emails, many phone calls, acting as a liaison between my doctor and the company,” said Elizabeth Fisher Smith, a 32-year-old public health instructor in New York City, whose Coram branch closed. A rare medical disorder has forced her to rely on PN for survival since 2017. “In the end, I got my supplies, but it added to my mental burden. And I’m someone who has worked in health care nearly my entire adult life.”
CVS had abandoned most of its less lucrative market in home parenteral nutrition, or HPN, and “acute care” drugs like IV antibiotics. Instead, it would focus on high-dollar, specialty intravenous medications like Remicade, which is used for arthritis and other autoimmune conditions.
Home and outpatient infusions are a growing business in the United States, as new drugs for chronic illness enable patients, health care providers, and insurers to bypass in-person treatment. Even the wellness industry is cashing in, with spa storefronts and home hydration services.
But while reimbursement for expensive new drugs has drawn the interest of big corporations and private equity, the industry is strained by a lack of nurses and pharmacists. And the less profitable parts of the business — as well as the vulnerable patients they serve — are at serious risk.
This includes the 30,000-plus Americans who rely for survival on parenteral nutrition, which has 72 ingredients. Among those patients are premature infants and post-surgery patients with digestive problems, and people with short or damaged bowels, often the result of genetic defects.
While some specialty infusion drugs are billed through pharmacy benefit managers that typically pay suppliers in a few weeks, medical plans that cover HPN, IV antibiotics, and some other infusion drugs can take 90 days to pay, said Dan Manchise, president of Mann Medical Consultants, a home care consulting company.
In the 2010s, CVS bought Coram, and Optum bought up smaller home infusion companies, both with the hope that consolidation and scale would offer more negotiating power with insurers and manufacturers, leading to a more stable market. But the level of patient care required was too high for them to make money, industry officials said.
“With the margins seen in the industry,” Manchise said, “if you’ve taken on expensive patients and you don’t get paid, you’re dead.”
In September, CVS announced its purchase of Signify Health, a high-tech company that sends out home health workers to evaluate billing rates for “high-priority” Medicare Advantage patients, according to an analyst’s report. In other words, as CVS shed one group of patients whose care yields low margins, it was spending $8 billion to seek more profitable ones.
CVS “pivots when necessary,” spokesperson Mike DeAngelis told KHN. “We decided to focus more resources on patients who receive infusion services for specialty medications” that “continue to see sustained growth.” Optum declined to discuss its move, but a spokesperson said the company was “steadfastly committed to serving the needs” of more than 2,000 HPN patients.
DeAngelis said CVS worked with its HPN patients to “seamlessly transition their care” to new companies.
However, several Coram patients interviewed about the transition indicated it was hardly smooth. Other HPN businesses were strained by the new demand for services, and frightening disruptions occurred.
Smith had to convince her new supplier that she still needed two IV pumps — one for HPN, the other for hydration. Without two, she’d rely partly on “gravity” infusion, in which the IV bag hangs from a pole that must move with the patient, making it impossible for her to keep her job.
“They just blatantly told her they weren’t giving her a pump because it was more expensive, she didn’t need it, and that’s why Coram went out of business,” Smith said.
Many patients who were hospitalized at the time of the switch — several inpatients stays a year are not unusual for HPN patients — had to remain in the hospital until they could find new suppliers. Such hospitalizations typically cost at least $3,000 a day.
“The biggest problem was getting people out of the hospital until other companies had ramped up,” said Dr. David Seres, a professor of medicine at the Institute of Human Nutrition at Columbia University Medical Center. Even over a few days, he said, “there was a lot of emotional hardship and fear over losing long-term relationships.”
To address HPN patients’ nutritional needs, a team of physicians, nurses, and dietitians must work with their supplier, Seres said. The companies conduct weekly bloodwork and adjust the contents of the HPN bags, all under sterile conditions because these patients are at risk of blood infections, which can be grave.
As for Coram, “it’s pretty obvious they had to trim down business that was not making money,” Reddick said, adding that it was noteworthy both Coram and Optum Rx “pivoted the same way to focus on higher-dollar, higher-reimbursement, high-margin populations.”
“I get it, from the business perspective,” Smith said. “At the same time, they left a lot of patients in a not great situation.”
***
Smith shares a postage-stamp Queens apartment with her husband, Matt; his enormous flight simulator (he’s an amateur pilot); cabinets and fridges full of medical supplies; and two large, friendly dogs, Caspian and Gretl. On a recent morning, she went about her routine: detaching the bag of milky IV fluid that had pumped all night through a central line implanted in her chest, flushing the line with saline, injecting medications into another saline bag, and then hooking it through a paperback-sized pump into her central line.
Smith has a connective tissue disorder called Ehlers-Danlos syndrome, which can cause many health problems. As a child, Smith had frequent issues such as a torn Achilles tendon and shoulder dislocations. In her 20s, while working as an EMT, she developed severe gut blockages and became progressively less able to digest food. In 2017, she went on HPN and takes nothing by mouth except for an occasional sip of liquid or bite of soft food, in hopes of preventing the total atrophy of her intestines. HPN enabled her to commute to George Washington University in Washington, D.C., where in 2020 she completed a master’s in public health.
On days when she teaches at LaGuardia Community College — she had 35 students this semester — Smith is up at 6 a.m. to tend to her medical care, leaves the house at 9:15 for class, comes home in the afternoon for a bag of IV hydration, then returns for a late afternoon or evening class. In the evening she gets more hydration, then hooks up the HPN bag for the night. On rare occasions she skips the HPN, “but then I regret it,” she said. The next day she’ll have headaches and feel dizzy, sometimes losing her train of thought in class.
Smith describes a “love-hate relationship” with HPN. She hates being dependent on it, the sour smell of the stuff when it spills, and the mountains of unrecyclable garbage from the 120 pounds of supplies couriered to her apartment weekly. She worries about blood clots and infections. She finds the smell of food disconcerting; Matt tries not to cook when she’s home. Other HPN patients speak of sudden cravings for pasta or Frosted Mini-Wheats.
Yet HPN “has given me my life back,” Smith said.
She is a zealous self-caretaker, but some dangers are beyond her control. IV feeding over time is associated with liver damage. The assemblage of HPN bags by compounding pharmacists is risky. If the ingredients aren’t mixed in the right order, they can crystallize and kill a patient, said Seres, Smith’s doctor.
He and other doctors would like to transition patients to food, but this isn’t always possible. Some eventually seek drastic treatments such as bowel lengthening or even transplants of the entire digestive tract.
“When they run out of options, they could die,” said Dr. Ryan Hurt, a Mayo Clinic physician and president of the American Society for Parenteral and Enteral Nutrition.
***
And then there are the shortages.
In 2017, Hurricane Maria crippled dozens of labs and factories making IV components in Puerto Rico; next came the covid-19 emergency, which shifted vital supplies to gravely ill hospital patients.
Prices for vital HPN ingredients can fluctuate unpredictably as companies making them come and go. For example, in recent years the cost of the sodium acetate used as an electrolyte in a bag of HPN ballooned from $2 to $25, then briefly to $300, said Michael Rigas, a co-founder of the home infusion pharmacy KabaFusion.
“There may be 50 different companies involved in producing everything in an HPN bag,” Rigas said. “They’re all doing their own thing — expanding, contracting, looking for ways to make money.” This leaves patients struggling to deal with various shortages from saline and IV bags to special tubing and vitamins.
“In the last five years I’ve seen more things out of stock or on shortage than the previous 35 years combined,” said Rigas.
The sudden retrenchment of CVS and Optum Rx made things worse. Another, infuriating source of worry: the steady rise of IV spas and concierge services, staffed by moonlighting or burned-out hospital nurses, offering IV vitamins and hydration to well-off people who enjoy the rush of infusions to relieve symptoms of a cold, morning sickness, a hangover, or just a case of the blahs.
In January, infusion professionals urged FDA Commissioner Robert Califf to examine spa and concierge services’ use of IV products as an “emerging contributing factor” to shortages.
The FDA, however, has little authority over IV spas. The Federal Trade Commission has cracked down on some spa operations — for unsubstantiated health claims rather than resource misuse.
Bracha Banayan’s concierge service, called IVDRIPS, started in 2017 in New York City and now employs 90 people, including 60 registered nurses, in four states, she said. They visit about 5,000 patrons each year, providing IV hydration and vitamins in sessions of an hour or two for up to $600 a visit. The goal is “to hydrate and be healthy” with a “boost that makes us feel better,” Banayan said.
Although experts don’t recommend IV hydration outside of medical settings, the market has exploded, Banayan said: “Every med spa is like, ‘We want to bring in IV services.’ Every single paramedic I know is opening an IV center.”
Matt Smith, Elizabeth’s husband, isn’t surprised. Educated as a lawyer, he is a paramedic who trains others at Columbia University Irving Medical Center. “You give someone a choice of go up to some rich person’s apartment and start an IV on them, or carry a 500-pound person living in squalor down from their apartment,” he said. “There’s one that’s going to be very hard on your body and one very easy on your body.”
The very existence of IV spa companies can feel like an insult.
“These people are using resources that are literally a matter of life or death to us,” Elizabeth Smith said.
Shortages in HPN supplies have caused serious health problems including organ failure, severe blisters, rashes, and brain damage.
For five months last year, Rylee Cornwell, 18 and living in Spokane, Washington, could rarely procure lipids for her HPN treatment. She grew dizzy or fainted when she tried to stand, so she mostly slept. Eventually she moved to Phoenix, where the Mayo Clinic has many Ehlers-Danlos patients and supplies are easier to access.
Mike Sherels was a University of Minnesota Gophers football coach when an allergic reaction caused him to lose most of his intestines. At times he’s had to rely on an ethanol solution that damages the ports on his central line, a potentially deadly problem “since you can only have so many central access sites put into your body during your life,” he said.
When Faith Johnson, a 22-year-old Las Vegas student, was unable to get IV multivitamins, she tried crushing vitamin pills and swallowing the powder, but couldn’t keep the substance down and became malnourished. She has been hospitalized five times this past year.
Dread stalks Matt Smith, who daily fears that Elizabeth will call to say she has a headache, which could mean a minor allergic or viral issue — or a bloodstream infection that will land her in the hospital.
Even more worrying, he said: “What happens if all these companies stop doing it? What is the alternative? I don’t know what the economics of HPN are. All I know is the stuff either comes or it doesn’t.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.Subscribe to KHN's free Morning Briefing.
Friday, February 3, 2023
Thursday, February 2, 2023
Physical interventions to interrupt or reduce the spread of respiratory viruses - Cochrane Library
The Cochrane Review on Masks is Damning
Masks have no good data to support them| It is a religion, not a science.
Tuesday, January 31, 2023
Affirmative Action with Leah Litman, Cost Implications with Dr. DeMartino, & Dr. John Mandrola
Here is a deep dive into cancer therapeutic costs, novel drug developments, and their effects on cost.
Can we afford it?
What about Long Covid? More science, less speculation. What causes the suffering, and ill effects, Is it vaccines?
An interview with constitutional law scholar Leah Litman, an Assistant Professor of Law at the University of Michigan, on Dr. Norman Wang and the intricacies of the laws on affirmative action. Next, we talk with Dr. Patrick DeMartino, a pediatric hematology/oncology fellow at Oregon Health & Science University, on his new paper out now in JAMA Internal Medicine: "Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018". Finally, we sit down with Dr. John Mandrola for an in-depth discussion on the intersection of medicine, politics, and advocate
CDC/FDA - EvuSheld no longer works as a prophylaxis – 61% of circulating variants now XBB.1.5 and 22% BQ.1.1 – what use are C19 mRNA injections targeting BA.4 and BA.5?
Information for Persons Who Are Immunocompromised Regarding Prevention and Treatment of SARS-CoV-2 Infection in the Context of Currently Circulating Omicron Sublineages — United States, January 2023
Saturday, January 28, 2023
Neurotechnologies for Alzheimer Disease Are Emerging: Here’s What We Know So Far -
Wednesday, January 25, 2023
Congress eliminates need for waiver to treat opioid use disorder
The California Medical Association (CMA) supports efforts to increase access to much-needed medication-assisted treatment for opioid use disorders. Across the country, many people suffering from opioid use disorder are unable to access medication-assisted treatment for their condition due to a lack of nearby physicians with waivers to prescribe buprenorphine.
Going forward, all prescriptions for buprenorphine only require a standard U.S. Drug Enforcement Agency (DEA) registration number. Additionally, there are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
Section 1263 of the Omnibus spending bill (the Medication Access Training Expansion Act) also establishes new training requirements for all prescribers of controlled substances, which will take effect June 21, 2023. The new law requires all prescribers of schedule II – V controlled substances to meet a one-time eight-hour training requirement on identifying, treating, and managing patients with opioid or other substance use disorders. (Certain physicians – including those board certified in addiction medicine – will be deemed to have met this training requirement through their specialty training and/or board certification. Click here for more details.)
DEA and the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) are actively working to provide additional guidance on these requirements.
Tuesday, January 24, 2023
CLINICAL TRIALS
The number and scope of clinical trials is daunting.
Alzheimer's Disease Clinical Trials
Arthritis Clinical Trials
Asthma Clinical Trials
Back Pain Clinical Trials
Cancer Clinical Trials
COVID-19 Clinical Trials
Chronic Cough Clinical Trials
Cluster Headaches Clinical Trials
Constipation Clinical Trials
Crohn's Disease Clinical Trials
Cytomegalovirus Clinical Trials
Depression Clinical Trials
Diabetes Type 1 Clinical Trials
Diabetes Type 2 Clinical Trials
Eczema Clinical Trials
Endometriosis Clinical Trials
Fatty Liver Disease Clinical Trials
Fibromyalgia Clinical Trials
Healthy Volunteer Clinical Trials
Heart Attack Clinical Trials
Heart Disease Clinical Trials
High Blood Pressure Clinical Trials
High Cholesterol Clinical Trials
Hodgkin's Lymphoma Clinical Trials
Irritable Bowel Syndrome Clinical Trials
Kidney Disease Clinical Trials
Knee Pain Clinical Trials
Lupus Clinical Trials
Lymphoma Clinical Trials
Migraine Clinical Trials
Melanoma Clinical Trials
Myelofibrosis Clinical Trials
Narcolepsy Clinical Trials
Obesity/Weight Loss Clinical Trials
Osteoarthritis Clinical Trials
Parkinson's Disease Clinical Trials
Pediatric Healthy Volunteers Clinical Trials
All Pediatric Clinical Trials
Psoriasis Clinical Trials
Prurigo Nodularis Clinical Trials
Remote Clinical Trials
Schizophrenia Clinical Trials
Smoking Clinical Trials
Stress Urinary Incontinence Clinical Trials
Stroke Clinical Trials
Traumatic Brain Injury Clinical Trials
Ulcerative Colitis Clinical Trials
Vaccine Clinical Trials
If you have found a clinical trial that you are interested in, simply follow the instructions listed below the clinical trial posting. Some clinical trial postings allow you to complete an interest form which is located at the bottom of the study posting. Other clinical trials will require you to complete an online questionnaire, which is also at the bottom of the posting. If you are interested in contacting the clinic directly you must fill out the contact form to receive an email containing the phone number if the investigator opted to include one.
Also, remember that you may always refer your friends and family members to clinical trials that they may be interested in.
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