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Thursday, April 11, 2019

Americans Are Dying From Kratom Overdoses: CDC

Although many people believe the herbal drug kratom to be harmless, new research has found that, in an 18-month period, 91 Americans lost their lives to fatal overdoses in which the drug was a contributing factor.
In seven of those cases, kratom was the only drug to show up in postmortem testing, said a team from the U.S. Centers for Disease Control and Prevention.
The study was based on information in a federal drug-overdose database. The database included records of all known fatal drug overdoses across 27 states from July 2016 through December 2017.
Besides the 91 deaths in which kratom consumption was at least a contributing factor, victims in another 61 fatal drug overdoses were found to have kratom in their bloodstreams, although other drugs may have been responsible for the deaths, according to a team led by Emily O’ Malley Olsen. She works at the CDC’s National Center for Injury Prevention and Control.
Kratom was involved in less than 1% of the more than 27,000 fatal ODs documented in the new study, the researchers stressed.
But they noted that some postmortem examinations might have missed the presence of kratom, so “these data might underestimate the number of kratom-positive deaths.”
What can’t be denied is that kratom — bought legally throughout the United States — is increasingly in the mix for drug addicts, one emergency medicine physician said.
“While kratom accounted for just under 1% of overdose deaths in the study, what’s most concerning is that nearly 80% of persons who died from kratom had a history of substance misuse,” noted Dr. Robert Glatter, who practices emergency medicine at Lenox Hill Hospital in New York City.
For example, 65% of people with fatal overdoses in which kratom was involved had also taken the often deadly opioid fentanyl, the CDC team said, while heroin was in the mix in about 33% of cases.
Prescription opioids, such as OxyContin or Vicodin, were also often found, the researchers said.
According to Glatter, people often turn to kratom — made from the leaf of a Southeast Asian plant — to ease pain. However, almost 90% of people who overdosed from kratom in the new study were not currently being treated by a doctor for pain.
“What that says is that many people are misusing kratom to treat their ongoing pain, placing them at higher risk for overdose as they escalate the amount they use,” said Glatter. He wasn’t involved in the CDC research.
He explained that “kratom tends to act as a stimulant when used at lower doses, but produces an opiate-like effect, or ‘high,’ at higher doses.”
It’s those “opiate-like” qualities that have caused the U.S. Food and Drug Administration to take a much closer look at kratom in recent years. In November of 2017, the FDA issued a warning to consumers against using kratom, and the U.S. Drug Enforcement Agency has now listed it as a “drug of concern.”
Kratom has not been approved for any medical use by the FDA.
The CDC team’s findings echo those of a study published in February in the journal Clinical Toxicology. That research was led by Henry Spiller, director of the Central Ohio Poison Center.
Spiller’s team tracked calls to U.S. poison control “hotlines” and found that calls involving kratom overdoses are soaring, rising 50-fold from 2011 to 2016.
“We’re now getting literally hundreds of cases a year versus 10 or 20,” Spiller said.
His team also identified 11 deaths associated with kratom use, including two in which kratom was used by itself and nine where kratom was used with other drugs.
Unfortunately, kratom is being promoted as a safe alternative to opioid painkillers for people with chronic pain, Spiller said.
“Because it’s a plant and it’s natural, at this point it’s unregulated,” Spiller said. “A lot of people have been Google-searching it for use in chronic pain and other things, and we’ve started to see a really significantly increased use and, in many cases, abuse of it.”
But taking too much kratom can cause some unintended health problems, including agitation, seizures, rapid heart rate and high blood pressure, Spiller said. In extreme cases, kratom overdose can put a person into a coma, stop their breathing or cause kidney failure.
“Just because it’s natural doesn’t mean it’s harmless,” Spiller said.
The new report was published April 12 in the CDC’s Morbidity and Mortality Weekly Report.
More information
The U.S. Food and Drug Administration has more about kratom.
SOURCES: Robert Glatter, M.D., emergency medicine physician, Lenox Hill Hospital, New York City; Henry Spiller, director, Central Ohio Poison Center, Columbus; April 12, 2019, Morbidity and Mortality Weekly Report

NYC Mandates Measles Vaccinations; Merck Is The Exclusive Manufacturer

After a failed public health campaign and an ineffective ban on unvaccinated school students, New York City Mayor Bill de Blasio is taking drastic measures to curb the nation’s largest measles outbreak in decades.
On Tuesday, the mayor declared a public health emergency requiring unvaccinated residents of Williamsburg, Brooklyn, to get the vaccine or pay a potential $1,000 penalty. De Blasio also warned he might temporarily close non-compliant yeshivas in the ultra-Orthodox Jewish community at the heart of the outbreak, according to The New York Times.
“This is the epicenter of a measles outbreak that is very, very troubling and must be dealt with immediately,” de Blasio said at a press conference. “The measles vaccine works. It is safe, it is effective, it is time-tested.”
Mayor Bill de Blasio
✔@NYCMayor
As a father, I know how much parents want their children to be safe and healthy. Don’t take this risk. If your child isn’t vaccinated against measles, get them vaccinated today. @NYCHealthy is ready to help provide the vaccination free of charge.
Mayor Bill de Blasio
✔@NYCMayor
Unvaccinated children in the zip codes of 11205, 11206, 11211 and 11249 may not return to school or daycare for the duration of this outbreak.
If you choose to not vaccinate, you will be fined. We have to protect our kids and our families.
The spreading anti-vaccination movement has contributed to 285 confirmed cases, including 21 requiring hospitalization, since the outbreak began this fall. More than 465 cases have been recorded nationwide since the start of the year. As of April 4, 2019 has already surpassed the case counts of eight of the last nine years, and it’s on pace to break the 2014 full-year record of 667.
It’s a nightmare for public health officials, but it’s good for Merck & Co., Inc. MRK 1.23%. The drugmaker is the exclusive manufacturer of the MMR II — measles, mumps, rubella — vaccine, which is generally distributed in two doses.
Notably, the drug represents a blip in Merck’s $42.29-billion in annual revenue. In combination with Proquad and Varivax, MMR II contributed just $1.798 billion in 2018. The package was still the fourth-largest seller in Merck’s leading pharmaceutical category.
Throughout the year, the combination recorded $392 million in the first quarter, $426 million in the second, $525 in the third and $455 in the fourth. Merck’s April 30 earnings report will give an indication of whether the outbreak has altered demand.

Vertex initiated with an In Line at Evercore ISI

Evercore ISI analyst Ravi Mehrotra initiated Vertex with an In-Line rating and a price target of $183. The analyst says the company has “great science, execution, and management”, but its multiple is the highest relative to its peers and appears to be “priced to perfection”. Mehrotra adds that the debate around EU pricing will intensify, becoming a “bigger and longer headwind”.

Sarepta initiated at Evercore ISI

Sarepta initiated with an Outperform at Evercore ISI. Evercore ISI analyst Ravi Mehrotra initiated Sarepta with an Outperform rating and a price targets of $175. The analyst cites the company’s opportunity in Duchenne muscular dystrophy and dominant position in its domain.
https://thefly.com/landingPageNews.php?id=2891645

Neurocrine initiated at Evercore ISI

Neurocrine initiated with an Outperform at Evercore ISI. Evercore ISI analyst Ravi Mehrotra initiated Neurocrine with an Outperform rating and a price targets of $113. The analyst cites his above-consensus estimates for Ingrezza at $1.76B, the multiple opportunities for long term upside to penetration rates, and its pipeline that is not being fully appreciated.
https://thefly.com/landingPageNews.php?id=2891647

Alnylam initiated at Evercore ISI

Alnylam initiated with an Outperform at Evercore ISI. Evercore ISI analyst Ravi Mehrotra initiated Alnylam with an Outperform rating and a price targets of $120, citing the “strength of its Onpattro franchise and high modality modularity.” The analyst contends that the company’s modular platform enables its “sustainable growth opportunities”, points to its Lumasiran Phase 3 results being a “resounding win”, and also notes that all of the company’s pipeline segments are advancing.
https://thefly.com/landingPageNews.php?id=2891651

Cerner and naviHealth Expand Relationship, Plan to Launch Offering

Health care providers that want to participate in Medicare’s Bundled Payments for Care Improvement Advanced program (BPCI Advanced) can soon look to Cerner, a global leader in health care technology, and naviHealth, an industry leader in post-acute care management, which plan to create a new offering for the program. The new value-based care offering is expected to support affordable and accessible health care centered on the patient.
Under BPCI Advanced, providers prospectively agree to a pre-defined reimbursement amount for 32 Centers for Medicare and Medicaid Services (CMS)-defined episodes of care or chronic conditions. Bundled payment offerings can support better health care experiences for consumers with greater cost transparency, while also improving efficiency and reducing waste for health systems and providers.
After working together for five years to streamline electronic workflows for post-acute discharge, Cerner and naviHealth anticipate launching an offering to support BPCI Advanced, with initial focus on the next CMS launch of the program in January 2020. Working together, Cerner and naviHealth plan to give health systems and providers the ability to effectively participate in bundled payment arrangements while driving improved clinical outcomes and financial results. The new value-based, electronic health record-agnostic offering is expected to support affordable and accessible health care centered on the patient.
Earlier this year, Cerner announced a new operating model focused on relentlessly seeking breakthrough innovation that will shape the health care of tomorrow. This expanded relationship is just one example of two world-class companies coming together to address one area of health care that is ripe for improvement and modernization, reimbursement models and the shift to value-based care. This new offering is expected to help both organizations advance their clients’ successes, provide better health experiences and outcomes, and ultimately become the partner of choice for innovation in this space.
“Cerner is strongly committed to the ongoing push by CMS to advance the BPCI program,” said Don Trigg, executive vice president, Strategic Growth, Cerner. “naviHealth has a proven post-acute care track record and an established bundled payment solution. We are excited for our technology to facilitate their go-to-market approach.”
naviHealth is one of the largest conveners, or risk sharing partners, in the BPCI Advanced program today, providing services in 22 states to more than 140 hospital partners, and managing billions of dollars of spend annually. Cerner’s HealtheIntent® big data platform and comprehensive care management technologies complement naviHealth’s predictive assessment tools, care management platform and care navigation expertise in managing patients from the hospital through post-acute care.