IPO Outlook For The Week: Silk Road Medical, NGM Biopharmaceuticals

NGM Biopharmaceuticals Inc (NGM) will issue nearly 6.7 million shares between $14 and $16 each Thursday on the Nasdaq. The offering represents 10.3 percent of outstanding shares. The clinical-stage biotech company advances candidates for non-alcoholic steatohepatitis, reverse liver fibrosis and type 2 diabetes.

Silk Road Medical Inc (SILK) will issue nearly 4.7 million shares between $15 and $17 each Thursday on the Nasdaq. The offering represents 16.3 percent of outstanding shares. Based in California, the medtech company develops and manufactures proprietary transcarotid medical devices for carotid artery disease.

https://www.benzinga.com/news/19/03/13439089/ipo-outlook-for-the-week-ruhnn-silk-road-medical-ngm-biopharmaceuticals-and-a-tr

Even a small amount of red and processed meat can be harmful

Research from Loma Linda University Health in California has suggested that consuming small amounts of red or processed meat can increase the risk of death when compared to individuals following a no-meat, vegetarian diet.

stockcreations | Shutterstock

The study included 72,149 individuals participating in the Adventist Health Study-2 (AHS-2), a large cohort study of Seventh-day Adventist men and women in the US and Canada.

Researchers were able to investigate the effects of low-level consumption of red and processed meats compared with the effects of not eating red or processed meat at all, as approximately 50 percent of Adventists follow a vegetarian diet. Those who are not vegetarian typically only eat small amounts of meat.

The health effects of a low meat diet versus a vegetarian diet were previously unknown, explained Saeed Mastour Alshahrani, lead author of the study:

We [wanted] to take a closer look at the association of low intakes of red and processed meat with all-cause, cardiovascular diseases, and cancer mortality compared to those who didn’t eat meat at all.”

According to the study, global meat consumption has increased in developing and developed countries, with red meat being the most commonly consumed meat in the US.

The study also describes links between red and processed meat and cardiovascular disease (CVD), diabetes, and certain types of cancer.

However, it notes that the studies that have produced these links between red and processed meat consumption and the above diseases left the question of whether excluding these meats from the diet would correlate with lower risk of disease incidence “unanswered”.

Red and processed meat has been linked to colorectal cancer

Both red meat and processed meat has been linked to an increased risk of colorectal cancer in particular, with one suggested cause involving haem, a compound that contains iron and provides red meat its color.

Haem can instigate the formation of carcinogenic compounds that damage the bowel lining, possibly leading to bowel cancer. Additionally, processed meat contains nitrites and nitrates that when digested, can form carcinogenic compounds.

Red meat includes beef, veal, pork, lamb, mutton, horse, and goat, and an intake limit has been recommended at three portions a week, equalling to 350-500g cooked weight.

Processed meats include any meat that has been smoked or cured, and meat that has been treated with chemical or salt preservatives. The types of meat classed as processed are bacon, salami, chorizo, corned beef, pepperoni, pastrami, hot dogs, and all types of ham.

Consuming processed meat is not recommended due to strong evidence that it causes colorectal cancer.

Meat-eaters were ‘younger and less educated’

The Adventist Health Study-2 was primarily created to investigate the effects of diet on cancer risk. For this new study, the researchers assessed the cohort’s diet with a food frequency questionnaire, and used the National Death Index for data collection on mortality. Around 90 percent of participants who ate meat only ate up to two ounces of red meat a day.

The study, which was recently published in the journal Nutrients, found that over a mean follow-up period of 11.8 years, 7,961 deaths occurred overall. Of these deaths, 2,598 were from cardiovascular disease, and 1,873 were cancer-related deaths.

When compared with “zero intake subjects”, which describes participants following a vegetarian diet, those with the highest unprocessed red meat intake were “younger, less educated, and less physically active.”

It was also shown that they also had a “higher prevalence of current smoking, alcohol use, and slightly higher BMI.”

Those with high intakes of unprocessed red meat also “tended to have lower intakes of cruciferous vegetables, fruits, whole grains, legumes, and nuts and seeds.” Their intake of eggs, dairy, and unprocessed poultry and processed meat was also higher.

Even small amounts of red and processed meat can be harmful

It was concluded that even diets containing small amounts of red and processed meat are associated with “moderately higher risks of all-cause and CVD mortality”.

However, the study states: “Processed meat alone was not significantly associated with risk of mortality. The combined intake of red and processed meat was associated with all-cause mortality […] and CVD mortality.”

The researchers also state in the study discussion that its results are in contrast to several US cohort studies that found “significant” associations between cancer mortality and red and processed meat consumption, and notes that this could be due to the fact that researchers adjusted for dietary variables including dairy, whole grains and legumes, which have been linked to a reduced risk of certain cancers.

The discussion goes on to explain that the study’s “lack of association for cancer mortality does not necessarily indicate no relationship to cancer incidence,” with vegetarian dietary patterns “not at lower risk of cancer mortality compared with nonvegetarians”, although this study’s particular cohort did suggest a “lower overall cancer incidence”.

Our findings give additional weight to the evidence already suggesting that eating red and processed meat may negatively impact health and lifespan.”

Dr. Michael Orlich, Co-author

Researchers also say that their study was able to fill an “important gap” in literature, in that they were “able to evaluate the association of red and processed meat at low consumption levels compared to zero-intake subjects, whereas other studies have only compared risk at higher intake levels.”

Source:

Red and Processed Meat and Mortality in a Low Meat Intake Population. Nutrients. 8 March 2019. 11(3), 622. DOI:10.3390/nu11030622.

https://www.news-medical.net/news/20190329/Even-a-small-amount-of-red-and-processed-meats-can-be-harmful.aspx

Alcohol, caffeine are common triggers of irregular heart rhythm

The most common triggers of atrial fibrillation – an irregular heart rhythm that’s a leading cause of stroke – are avoidable behaviors like drinking alcohol or coffee, a recent study suggests.

People don’t always realize when they’re experiencing atrial fibrillation, or AFib, but some feel unpleasant chest palpitations or a racing, irregular heartbeat.

Some patients have AFib 24 hours a day. In others, the irregular heartbeat is “paroxysmal,” that is, it comes and goes. For the current study, reported in the journal Heart Rhythm, researchers surveyed 1,295 patients with symptomatic paroxysmal AFib and found the most common behaviors that triggered episodes of the arrhythmia were alcohol consumption, caffeine consumption and exercise.

The survey asked about 11 possible triggers: alcohol, caffeine, lack of sleep, exercise, not exercising, consuming cold beverages, consuming cold foods, high sodium diet, consuming large meals, dehydration, and lying on one’s left side.

About three-fourths of the patients said at least one of those behaviors triggered AFib some or all of the time.

Alcohol consumption was cited by 35 percent, followed by coffee drinking (28 percent), exercise (23 percent) and lack of sleep (21 percent).

The researchers say it’s possible the behaviors don’t actually trigger the episodes but instead make the symptoms worse.

The study wasn’t designed to tell whether cutting back on these triggers would reduce the frequency of AFib episodes.

Still, coauthor Dr. Gregory Marcus from University of California, San Francisco told Reuters Health, “Many, if not most of these triggers are modifiable, and we feel theoretically the patient does have some power to potentially influence the probability of an episode occurring.”

Dr. Deepak Bhat, a cardiologist at Brigham and Women’s Hospital Heart & Vascular Center in Boston who was not associated with the study, agreed. He told Reuters Health by phone, “Importantly, the information in this paper is actionable. People with episodes of atrial fibrillation that appear to be triggered by alcohol or caffeine, for example, can avoid these.”

Associations between alcohol and AFib are well known, but the link with coffee is controversial, Bhat said. “Some experts dispute that association . . . though I have seen it in many patients,” he added.

Bhat noted that while exercise is a healthy habit, strenuous exercise after long periods of not exercising has been known to trigger heart arrhythmias.

Marcus said the idea for the research came from a summit that brought together patients and researchers to identify topics patients thought were not well covered by the scientific community. Patients with atrial fibrillation unanimously agreed that they wanted to know more about triggers.

“While there has been quite a bit of research investigating the root cause of the first diagnosis of (AFib), there has not been sufficient investigation into understanding why an episode happens when it happens,” Marcus said.

In AFib, the heart’s two small upper chambers beat irregularly and too fast, “quivering like a bowl of gelatin,” according to the American Heart Association. As a result, the heart can’t pump properly and the body doesn’t get enough oxygen-carrying blood. AFib can lead to serious medical problems including stroke and heart failure. Treatments include medication to regulate the heart rate or heart rhythm, blood thinners to help prevent clots from forming, and in some cases, electric shocks to reset the beat of the heart.

SOURCE: bit.ly/2Wwo13q Heart Rhythm, online February 14, 2019.

https://www.reuters.com/article/us-health-heart-afib/alcohol-caffeine-are-common-triggers-of-irregular-heart-rhythm-idUSKCN1RA2I1

As Dems Talk Single Payer, Insurance Companies Tighten Grip On Medicare

The creation of another national health insurer planning to grow its private Medicare Advantage business comes as proposals grab headlines for a single payer government-run approach that could uproot such companies.

Health insurer Centene last week announced plans to buy WellCare Health Plans for more than $15 billion in a deal that will make the combined company a stronger player in the fast-growing Medicare Advantage business. Both are already growing rapidly administering Medicaid benefits for states and selling individual coverage under the Affordable Care Act.

“With Medicare, it’s actually one of the things we are most excited about,” WellCare CEO Ken Burdick told analysts last week during an hour-long conference call to discuss the merger. “We see this transaction as fundamentally improving our Medicare operation. We think it’s going to really propel us into a much more competitive position going forward.”

Medicare Advantage plans contract with the federal government to provide extra benefits and services to seniors, such as disease management and nurse help hotlines, with some even providing vision and dental care and wellness programs. And the Centers for Medicare & Medicaid Services is changing regulations to allow Medicare Advantage plans to provide broader coverage in the future and coverage of more supplemental health benefits.

But some Democrats in Congress and several running for their party’s nomination for President in 2020 favor a single payer version of “Medicare for All” that would uproot the private insurance system and bring an end to the health insurance company’s role in administering benefits. Phasing out the health insurance industry is a part of U.S. Sen. Bernie Sanders’ presidential campaign and he’s led the charge on the Medicare for All Actthat has support from other Democrats running for president including Sens. Elizabeth Warren (D-Mass), Kirsten Gillibrand (D-New York) and Kamala Harris (D-California).

Yet talk of single payer approach comes as seniors flock to Medicare Advantage, which is administered by many health insurance companies and is quickly approaching half of the U.S. Medicare enrollment.

The Centene-WellCare deal would create a business with more than 900,000 seniors enrolled in Medicare Advantage, helping it compete with national health insurers Cigna, Humana, UnitedHealth Group and the Aetna health insurance unit of CVS Health.

Across the country, more than 22 million seniors are signed up for Medicare Advantage with projections that there will be nearly 40 million or 50% market penetration by the end of 2025.

Though the health insurance lobbies, America’s Health Insurance Plans and the Blue Cross Blue Shield Association, are spending a lot of time, money and attention to the single payer push, Centene’s CEO Michael Neidorff takes the debate in stride, calling it “headline volatility.”

But where some executives may see “uncertainty” as Neidorff describes it, he sees opportunity. “We see that as an ideal time to take appropriate actions based on today’s facts,” Neidorff, who lead the combined company as chairman and CEO, told analysts last week. “When it comes together, we will be in a stronger position . . . no matter what happens.”

https://www.forbes.com/sites/brucejapsen/2019/03/31/as-democrats-talk-single-payer-insurers-tighten-grip-on-medicare/#1dae515978f7

RFK Jr. addresses Conn. vax skeptics as lawmakers eye axing religious exemption

Despite scientific studies that show vaccines are safe, hundreds of skeptics are urging state lawmakers not to eliminate a provision allowing parents to exempt their children from immunizations for religious reasons.

Robert F. Kennedy Jr., an environmental lawyer whose father, Robert F. Kennedy, served as U.S. attorney general and a U.S. Senator, stoked their mistrust, telling the crowd at the Legislative Office Building on Tuesday that the government and the media have formed an alliance with pharmaceutical companies to minimize the health risks posed by vaccines.

“I learned from my dad, don’t trust people in authority,” said Kennedy, whose father was a prominent anti-war activist and a Democratic candidate for president before he was assassinated in 1968. “People in authority lie.”

Kennedy was the main speaker at a forum on vaccines hosted by state lawmakers who are seeking to preserve the religious exemption. A separate informational session featuring Kennedy, along with scientists who endorse immunizations as a way to prevent the spread of disease, had also been scheduled for Tuesday at the Capitol, but that forum was abruptly canceled Monday night after two of the physicians invited to speak pulled out, saying they did not want to provide Kennedy credibility by appearing alongside him.

“Medical professionals began trying to kill the forum because they felt we would be legitimizing debunked claims from someone who has demonstrated the inability to sift through the truth from fiction,” state Rep. Josh Elliott, the Hamden Democrat who organized that event, wrote on Facebook. “I am concerned with the perspective the medical community has taken — in that it is better not to have the conversations publicly. If we believe in the science, we have nothing to be concerned of. We cannot speak to those who are true believers — but there are more out there who are simply uneducated on the science of vaccination.”

Elliott is among those pushing to eliminate the religious exemption.

A national outbreak of measles has prompted some states to propose tighter rules on vaccinations. In Connecticut, which has one of the nation’s highest vaccination rates, all children are required to be immunized against highly contagious viruses such as measles, rubella, mumps and chickenpox before enrolling in public school.

But Connecticut allows parents to opt out of vaccinating their children on religious grounds or for medical reasons. The number of state residents seeking the religious exemption has increased in recent years, alarming some lawmakers. In 2008, 466 children had the religious exemption; last year, the total reached 1,255 schoolchildren, according to the 2018 school survey. That figure includes public and private school kindergartners and seventh-graders.

But others framed the issue as a matter of parental rights. “There’s a lot more discussion that we should be having on this issue,” said Rep. Vin Candelora, R-North Branford. “Everybody has the right to vaccinate their children, just as everyone has the right to exercise the religious exemption.”

Efforts to repeal the exemption did not gain traction in the legislature’s public health committee. But some legislators who want to preserve the provision fear a repeal measure could be tucked into another bill later this spring.

That concern brought together two lawmakers who don’t generally agree on much: Reps. Anne Dauphinais, a conservative Republican from Killingly, and Jack Hennessy, a progressive Democrat from Bridgeport.

“We wanted to be a voice for our constituents who were concerned about mandating vaccines,” Dauphinais said. “They don’t want to be told how to treat their children. They want to look at the risks and benefits, where’s there’s risk there should be choice.”

Dauphinais, who was trained as a nurse and once worked for a pharmaceutical company, said she regretted vaccinating her own children, who are now grown.

Hennessey said he views the issue through the lens of the First Amendment.

Attendees of a presentation by Robert F. Kennedy Jr. at the Legislative Office Building on Tuesday raise their hands after Kennedy asked: “Raise your hands if you have a family member that has been injured by a vaccine.” (Mark Mirko/Hartford Courant)

Multiple studies have refuted claims by Kennedy and other anti-vaccination activists that some vaccines increase the risk for autism or cause injury and sickness. According to the Centers for Disease Control, there is no link between autism and vaccines and adverse reactions to vaccinations are extremely rare.

Kennedy embraces the science behind climate change but questions studies that show vaccines are generally safe. He says vaccines have left countless children hurt or sickened. At one point, he asked the large crowd at the forum if their children had been injured by a vaccine and dozens of hands shot up.

“We’re here just to share the truth,” said Megan Belval, a mother from Avon, “to protect our right to determine what is injected into our bodies and our children’s bodies. There’s nothing more basic than that.”

https://www.courant.com/politics/hc-pol-vaccines-connecticut-forum-20190319-nwuvduskrvbbtmge7fz7ke7zne-story.html

Getting rid of debt may make your brain work better

A new study has a whole different take on what debt relief means.

Getting rid of debt doesn’t just unburden finances, it takes a weight off the mind that clears up cognitive functioning, lessens anxiety and improves impulse control.

The findings come from researchers at the National University of Singapore’s Social Service Research Centre, who studied almost 200 low-income people who unexpectedly had portions of their long-running mortgage, utility and municipal debts paid down by a charity.

Researchers tested participants before and after their windfalls on their ability to spot matches and mismatches. The recipients were also tested for generalized anxiety disorder and their ability to make more beneficial financial decisions.

The study found:

• Average error rates in the cognitive function tests fell to 4% after the debt was paid down, compared to a 17% error rate beforehand.

• The proportion of participants showing generalized anxiety disorders went from 78% to 53% after the debt relief.

• Numbers of people showing so-called “present bias,” which favors instant gratification, dropped to 33% from 44%, a sign that their impulse control had improved.

‘Because debt impairs psychological functioning and decision-making, it would be extremely challenging for even the motivated and talented to escape poverty.’

— Dr. Ong Qiyan, National University of Singapore

The university’s Dr. Ong Qiyan said the findings showed the costs of being poor that aren’t measured on a balance sheet. “Our study shows that because debt impairs psychological functioning and decision-making, it would be extremely challenging for even the motivated and talented to escape poverty,” she said.

Of course,the experiment played out on the other side of the globe and involved a very small number of people.

The findings are in line with previous research in the U.S. on the psychological toll of living in poverty. When people live in “chronic scarcity” — meaning they lack sufficient money, housing and food to thrive — their brains become overtaxed because they’re coping with emergency after emergency, research by the nonprofit consulting firm ideas42 found. That in turn can diminish self-control and harm people’s ability “to evaluate options and make high-quality decisions,” wrote ideas42. “In short, scarcity makes us less insightful, less forward-thinking, and less controlled,” the study concluded.

Many Americans are well-acquainted with the stress that financial uncertainty can create. As the nation faces $1.5 trillion in outstanding student debt, a third of students in a survey last year said their student loan bills were a major source of stress. One man said he and his wife would cry the day they paid their last student loan bill. Debt can also affect your dating prospects. Three quarters of people in one survey said credit-card debts would be a turn-off in a potential mate.

Researchers said the Singapore study was another look at so-called “bandwidth taxes,” which are part of the reason some people stayed mired in poverty. “The demands of daily life under scarcity create ‘bandwidth taxes’ that sap mental resources, impairing cognitive ability and causing counterproductive behavior which perpetuates poverty,” the researchers wrote in the study, which was published in the Proceedings of the National Academy of Sciences of the United States of America.

One way to less the bandwidth taxes? Consolidate debt to simplify the pay-off experience, researchers suggested.

https://www.marketwatch.com/story/getting-rid-of-debt-may-actually-make-your-brain-work-better-2019-03-29?siteid=rss&rss=1

LabCorp and Covance tap Mission Bio for single-cell genomics sequencing

LabCorp has tapped cell sequencer Mission Bio to provide single-cell DNA analysis and precision genomics in a collaboration with its Covance drug development business.

In addition, LabCorp and its contract research arm will also evaluate Mission Bio’s Tapestri DNA sequencing platform and explore its use in clinical diagnostics and the development of new companion diagnostic tests.

“There is keen interest in improving the identification of residual cancer cells that remain after treatment, to provide more specific information about treatment response and remission durability,” said Covance Chief Scientific Officer Steve Anderson.

“A more sensitive test for minimal residual disease, which is possible through single-cell genomics, has great potential to streamline clinical trials and help providers manage their patients’ care more effectively,” Anderson added.

The single-cell Tapestri platform is designed to identify the individual cancer cells that may drive disease, by detecting rare subclones and co-occurring cancer mutations, while measuring therapy responses and disease progression.

The collaboration comes after LabCorp’s investments in Mission Bio, including in a $30 million series B round completed last December.

“The combination of LabCorp’s diagnostics and drug development capabilities makes it the ideal partner to expand our global ecosystem by opening access to the biopharmaceutical industry,” Mission Bio CEO Charlie Silver said in a statement. “With this partnership, we can now offer complete support from preclinical and biomarker discovery through to clinical trials and commercialization.”

Separately, Mission Bio also inked an agreement with the Carlsbad, California-based contract diagnostics manufacturer Argonaut Manufacturing Services, to help build out its supply chain and commercialization of its Tapestri platform. The financial details for both of Mission Bio’s agreements have not been disclosed.

https://www.fiercebiotech.com/medtech/labcorp-and-covance-tap-mission-bio-for-single-cell-genomics-sequencing