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A Staggering Blow to US Health Care

Just hours after announcing some new ways to destabilize the health-insurance markets created by the Affordable Care Act, on Thursday President Donald Trump delivered a direct blow to a crucial aspect of the law itself: No longer will the federal government reimburse insurance companies for reducing out-of-pocket costs for poorer customers, as the law requires them to do.

This long-feared step compounds all the damage the president has so far inflicted, by pushing insurers to hike premiums or leave the individual insurance market altogether. Trump may not recognize the harm this does to Americans’ health and peace of mind. But Congress should. Democrats and Republicans must come together to officially appropriate the payments that the president has recklessly ordered to be withheld.

A bipartisan effort to shore up the individual insurance market was under way in the Senate just a month ago, before a last-ditch attempt to repeal Obamacare stopped it in its tracks. Its leaders — Republican Lamar Alexander of Tennessee and Democrat Patty Murray of Washington — need to pick up where they left off.

In return for Republicans’ agreeing to fund the so-called cost-sharing reduction payments to insurers, Democrats could allow states greater leeway to determine the minimum requirements for insurance policies sold on their exchanges. But that discretion can’t be unlimited: States should not be allowed to simply waive Obamacare’s “essential health benefits.”

First, however, the bipartisan conversation must resume.

On Friday morning, Trump tweeted that Obamacare is “imploding.” In fact, he has used every tool at his disposal to make it collapse. His decision to end cost-sharing payments throws the individual health-insurance market into chaos just as the fall enrollment season is about to begin. Chaos, indeed, seems to have been Trump’s intent, or he would not have ended the payments so abruptly. Now it’s Congress’s responsibility to shore up the law and stabilize the health-care system.

    –Editors: Mary Duenwald, Michael Newman.

    To contact the senior editor responsible for Bloomberg View’s editorials: David Shipley at
    davidshipley@bloomberg.net
    .

    Article source: https://www.bloomberg.com/view/articles/2017-10-13/a-staggering-blow-to-u-s-health-care

This Is The Latest Asian Country To Become A Hot Spot For Chinese Medical Tourists

COMO Shambala Estate

Practicing Tai Chi at a residential health retreat in Bali, Indonesia

From being one of the most underutilized passports in the world, Chinese tourists have breathed new life recently into airlines, cruise ships and the global hospitality industry as a whole. Much of the journeying began after looser visa restrictions negotiated by the government started in the late ’90s. The country went from 10 million outbound movements in 2000 to 122 million recorded this past year , according to figures from the China Tourism Academy (CTA). To put those numbers into perspective, only 11 countries in the world have a total population comparable to that size.

Chinese travelers took full advantage of the eight-day long “Golden Week” holiday, one of two week-long national holidays observed by mainland China, to globe-trot. Many though opted not to sightsee, but rather to take the opportunity to improve their health. Chinese online travel booking site Ctrip revealed 500,000 Chinese travelled overseas for medical-related services in 2016, a five-fold jump year-on-year.

COMO Shambhala Estate

Patient doctor medical consultation

Amongst the most popular destinations for the Chinese to visit was Thailand, recording over nine million trips from China so far this year. But database provider Euromonitor found that Indonesia posted the highest tourism volume growth of 30% so far in 2017. A long-time favorite of Australians, Bali became a hot spot for Chinese travelers — their numbers surpassed the Aussies for the first time ever reaching 150,000 arrivals, becoming the second most visited island by Chinese tourists after Phuket. And that’s even with the imminent danger of Mount Agung threatening to erupt at any moment.

Indonesia is a popular destination among Chinese tourists. Image: Vecteezy.

Wanderlusting for wellness 

“I want to relieve stress, I want more energy, I want to feel better, lose weight, I want to be happy.” This is what the majority of Dr. Nancy Kim’s patients tell her. She is the oriental medicine consultant at the COMO Shambhala Estate deep in the jungles of Bali where travelers retreat for a heaping dose of mental and physical healing.

COMO Shambhala Estate

COMO Shambhala Estate accommodation.

The estate started offering Ayurveda, an ancient Indian remedy system 13 years ago, long before the wellness boom became mainstream. The property has since branched into acupuncture, Balinese therapy, chi gong, herbal therapy, and even gyro-tonics that is said to promote longevity.

Ctrip’s findings showed that the average spending on medical tourism is around ten times greater than regular outbound Chinese travel. “Most of my patients are very successful professionals… they are overworked, overfed, undernourished and unfulfilled,” says Kim as she profiles the typical guest that checks into the retreat. “We simplify the experience of health to make it approachable.”    

COMO Shambhala Estate

Acupuncture treatments

Splurging on health tourism

The statistics from Ctrip also concluded that medical care services ranked fourth among the top 10 leisure activities that the site has to offer — whether for general health exams, early cancer screening, genetic-testing or cosmetic surgery which is extremely popular for affluent females traveling to South Korea. Japan’s cancer prevention and early detection programs are also amongst the costliest, but the high price tag doesn’t stop the Chinese from coming. Medical tourism services have now extended to treatments such as placenta anti-aging, living cell therapy, hepatitis c health care and physical therapy.

China’s medical outbound tourism spending is forecasted to grow through 2022.

Another resident doctor of naturopathy at COMO, Dr. Vinod Nair takes a holistic approach by reading a patient’s pulse and giving a facial diagnosis incorporating the five elements of nature — metal, wood, water, fire and earth. He subscribes to the belief that physical ailments are manifestations of emotions and the mind. In his practice, Nair interprets dreams and prescribes exercise and food as medicine.

COMO Shambhala Estate

Meditation to restore health by balancing the body’s natural energy system.

Make Indonesia a medical destination

As analysts declare Indonesia the “next wave” destination to watch, the local government is targeting 10 million Chinese tourists by 2019. The country is creating three additional tourism focused economic zones and are in the process of courting foreign investors to build more hotels, resorts and entertainment facilities. “Starting next year, we’ll offer just wellness programs without lodging,” Kim says of COMO’s plans to bring more travelers to the property.

To further develop so called “special-interest tourism,” the tourism and health ministry have made it a priority to make Indonesia a medical and wellness destination. To encourage more inbound traffic, Joko Widodo’s administration has plans to roll out stimulus for airlines to open more routes beyond Bali and Jakarta . Meanwhile the Indonesian Chamber of Commerce has called on China to increase the number of flight connections to at least 25 Chinese cities.

Article source: https://www.forbes.com/sites/pamelaambler/2017/10/15/will-travel-for-health-chinese-go-abroad-for-medical-treatments/

Obesity among all US adults reaches all-time high

(CNN)The United States will not be escaping the obesity epidemic crisis anytime soon: Nearly 40% of adults and 19% of youth are obese, the highest rate the country has ever seen in all adults, according to research released Friday by the National Center for Health Statistics.

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FDA backs move to make ‘bespoke’ condoms because the average size of 6.69 inches is TOO BIG for American men so …

  • The average erect penis size in America is 5.57 inches, about an inch shorter than the standard condom size
  • Experts believe this is one of the main reasons why just one-third of single American men use a condom during sex
  • Now the FDA has made a policy change that will allow companies to make smaller condoms 

Mia De Graaf For Dailymail.com

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A company is making smaller ‘bespoke’ condoms for American men, since the average size of 6.69 inches is too big. 

Recent CDC figures on condom use revealed just a third of single men use the rubber protection, and one of the most common reasons for non-users is that they ‘slip off’.  

Indeed, a study by Indiana University on almost 2,000 men revealed the average length is 5.57 inches – about an inch shorter than the standard condom size. 

Now the Food and Drug Administration, which regulates health industry standards, has conceded that there is a need for smaller condoms in a desperate bid to lower the rates of sexually transmitted diseases and unwanted pregnancies.

The agency has made a policy change to allow manufacturing companies to make condoms of all sizes. 

The average erect penis in America is 5.57 inches, an inch shorter than the standard condom size. The FDA has made a policy change that will let companies make smaller condoms

In doing so, it has given the green light to myONE Perfect Fit, a custom brand of condoms made by Boston company Global Protection Corp, which has been lobbying for a change for more than seven years.

The standard condom is between 6.7 and 8.3 inches long, and around 4.1 inches in width. 

Data collated by ONE Condoms found condoms only fit 12 percent of men. The rest have varying widths and lengths that are not catered to by the one-size-fits-all approach.

It sits in line with scientific research. 

The most high-profile study, conducted by Dr Debby Herbenick at Indiana University, asked 1,661 men in the U.S. to give the size of their penis.

Researchers were not involved in the measuring, leaving this practical aspect to each individual.

According to Dr Herbenick, she trusted men to give accurate measurements, since any exaggeration would simply leave them with a poor-fitting condom.

‘If they reported a bigger-than-reality size to us, they would get a baggier condom,’ she said. ‘If they reported a smaller-than-reality size to us, the condom would be too tight.’ 

The study documented varying lengths – from 1.5 inches to just over 10 inches.

The research team also found that the size of the erect penis varied depending on how it was achieved. Oral sex proved more arousing than masturbation or being stimulated only by sexual fantasies. 

To account for variability, ONE Condoms offers 60 different dimensions, from 4.9 to 9.4 inches in length and from 3.5 to 5.0 inches in width.

Davin Wedel, president of ONE Condoms, explained: ‘You might be able to squeeze your large hands into a size-small glove, but that doesn’t mean it will be comfortable to wear.

‘We want the world to know you shouldn’t have to sacrifice comfort for safety when it comes to condoms. Whether big, small or in between, myONE has a condom perfect for you.’

To buy a bespoke condom, men need to measure themselves or go print of a measuring kit from the ONE website. They can also order sample sizes of one bigger and one smaller than their size, in case the measurements were a bit off.  


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Article source: http://www.dailymail.co.uk/health/article-4978398/FDA-make-smaller-condoms-men-s-smaller-penises.html

Trump Brags About Tanking Insurer Stocks With Health Subsidy Cut

Donald Trump boasted about triggering a decline in health insurance stocks with his decision to end federal subsidies to those companies that help low-income Americans afford their medical coverage.

“Health Insurance stocks, which have gone through the roof during the ObamaCare years, plunged yesterday after I ended their Dems windfall!” the president told his 40.5 million Twitter followers on Saturday.

Shares of insurers still present on Affordable Care Act exchanges slumped on Friday. St. Louis-based Centene Corp. dropped more than 3 percent. Even large health insurers that have mostly or entirely exited the Obamacare exchanges saw an impact, and publicly traded hospital chains fell sharply as well. Hospital operator Tenet Healthcare Corp. tumbled 5 percent.

Trump’s tweet was a departure from his regular comments taking credit for strength in the U.S. stock market. “It would be really nice if the Fake News Media would report the virtually unprecedented Stock Market growth since the election,” he tweeted on Wednesday.

Analysts considered cutting fourth-quarter and 2018 earnings estimates for insurers and hospitals. “The effect of the order is likely to be profoundly destabilizing,” Mizuho Securities analyst Sheryl Skolnick wrote in a note to clients.

After months of pinning the blame for Obamacare’s shortcomings on Democrats and watching his own party fail to act, Trump, with two actions on Thursday, took ownership of a struggle that’s consumed Republicans for seven years.

Feeling the Pain: Health-Related Shares Fall

The decision to end the government subsidies to insurers was Trump’s most drastic yet among several taken to undermine his predecessor’s signature achievement. Trump on Thursday also signed an executive order directing regulators to pass rules that would allow cheaper, less regulated short-term health plans to be offered.

Ending the insurer subsidies could cost the government some $200 billion over the next decade, because even if the payments are dropped — Trump’s move is being contested in court — other, more costly subsidies paid to consumers will continue.

The move lobbed a live bomb at Republican lawmakers, just over a year before mid-term congressional elections, after he publicly berated the party’s Senate leadership for being unable to fulfill its longstanding promise to repeal the law.

“We’re taking a little different route than we had hoped,” Trump said Friday at an event with a conservative group in Washington. “Because Congress, they’re forgetting what their pledges were.”

The move kicks down one of the pillars of a law designed to cut the number of uninsured Americans and disrupts the health-care industry, which accounts for 17 percent of the U.S. economy.

Force Negotiations

Trump suggested he was trying to force negotiations with Democrats on a health-care plan that could pass muster with the Republican majorities in the House and Senate.

“What would be nice is if the Democratic leaders should come over to the White House,” he told reporters Friday. “If they came over, maybe we could make a deal.” 

But if no fix emerges before the 2018 congressional elections, Republicans may have a hard time convincing voters to hold Democrats responsible when they control the Senate, House and White House.

Senator Ted Cruz of Texas warned fellow Republicans at a meeting for conservative donors that they faced a “bloodbath” in next year’s election if they don’t deliver results on health care and tax cuts.

Adding to the political peril, the battle increases the chances of a government shutdown when agency spending authority expires on Dec. 8. Democrats are all but certain to demand a resumption of the cost-sharing reduction subsidies in exchange for their support of any final spending agreement. 

The administration, meanwhile, is signaling it won’t go for what Trump called “payoff to insurance companies” or any other Obamacare fix without getting something in return.

While Trump has called the Affordable Care Act a “nightmare,” polls show the public disagrees. Two-thirds of Americans say they want the president to work with Congress to improve Obamacare, according to a poll from the Kaiser Family Foundation conducted before Trump’s action was announced.

The most prominent proposal to fix the law, being crafted by Republican Senator Lamar Alexander of Tennessee and Democratic Senator Patty Murray of Washington, would combine continued cost-sharing subsidies with added flexibility for states to determine the offerings in the individual insurance market. Even if Senate Majority Leader Mitch McConnell were to allow a vote on the Senate floor, conservative opponents would likely filibuster the measure and slow debate.

Trump’s budget director Mick Mulvaney told Politico on Friday that Trump won’t support the Alexander-Murray proposal as it stands or without getting a significant concession on funding for other priorities, potentially including construction of the proposed wall on the U.S. border with Mexico.

The individuals hardest hit by the president’s decision to cut off the cost-sharing subsidies won’t be the low-income people who receive the help, since insurers are required to continue offering them lower deductibles and copays, even if the government funding ends.

Higher Premiums

Instead, middle-income people who buy their own health insurance without subsidies will bear the burden. That group numbers roughly 8 million, compared to about 10 million who get subsidies. They are likely to face higher insurance prices for 2018 as insurers look to recoup their subsidy shortfall by raising premiums.

“Ironically, it is these unsubsidized folks who have complained the loudest about Obamacare’s big premiums and deductibles,” Robert Laszewski, who runs Health Policy and Strategy Associates, a Washington consulting firm, said by email. “They will now have even more to complain about.”

Where Democrats saw deliberate sabotage, Republicans saw vindication.

“Obamacare has proven itself to be a fatally flawed law, and the House will continue to work with Trump administration to provide the American people a better system,” House Speaker Paul Ryan said in a statement.

Senate Minority Leader Chuck Schumer told reporters on a conference call that withdrawing the subsidies is “one of the worst things the president could do to sabotage our health-care system.”

— With assistance by Justin Sink, Jennifer Jacobs, and Terrence Dopp

    Article source: https://www.bloomberg.com/news/articles/2017-10-13/trump-takes-over-obamacare-political-risks-with-end-of-subsidies

Wine Country fires’ smoke fouls Bay Area air, creates health hazard

http://www.sfgate.com/health/article/Wine-Country-fires-smoke-fouls-Bay-Area-air-12274314.php


Updated 11:26 pm, Thursday, October 12, 2017

  • A woman in Napa wears a bandanna over her nose and mouth on Monday in an effort to protect herself from the smoke engulfing much of the region. Photo: Leah Millis, The Chronicle

Caption

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Mrunalini Kulkarni photographed the smog seen in Oakland on Thursday, Oct. 12, 2017. 

Mrunalini Kulkarni photographed the smog seen in Oakland on Thursday, Oct. 12, 2017. 


Photo: Courtesy Of Mrunalini Kulkarni

Sharie Michalec photographed the smog seen in Benicia on Wednesday, Oct. 11, 2017. 

Sharie Michalec photographed the smog seen in Benicia on Wednesday, Oct. 11, 2017. 


Photo: Courtesy Of Sharie Michalec

Carlin DeCato photographed the smog seen in San Francisco on Wednesday, Oct. 11, 2017. 

Carlin DeCato photographed the smog seen in San Francisco on Wednesday, Oct. 11, 2017. 


Photo: Courtesy Of Carlin DeCato

Arie Quick photographed the smog seen in Danville on Thursday, Oct. 12, 2017. 

Arie Quick photographed the smog seen in Danville on Thursday, Oct. 12, 2017. 


Photo: Courtesy Of Arie Quick

Serajeddin Dabnun photographed the smog seen in San Francisco on Wednesday, Oct. 11, 2017. 

Serajeddin Dabnun photographed the smog seen in San Francisco on Wednesday, Oct. 11, 2017. 


Photo: Courtesy Of Serajeddin Dabnun

Larry Braverman photographed the smog over San Francisco on Monday, Oct. 9, 2017. 

Larry Braverman photographed the smog over San Francisco on Monday, Oct. 9, 2017. 


Photo: Courtesy Of Larry Braverman

Jonathan Leonard photographed the smog over San Francisco on Oct. 9, 2017. 

Jonathan Leonard photographed the smog over San Francisco on Oct. 9, 2017. 


Photo: Courtesy Of Jonathan Leonard

Claudia Rice photographed the smog over the Berkeley Marina. 

Claudia Rice photographed the smog over the Berkeley Marina. 


Photo: Courtesy Of Claudia Rice

Michael Hanrahan photographed the smog over San Francisco from Hawk Hill on Oct. 9, 2017. 

Michael Hanrahan photographed the smog over San Francisco from Hawk Hill on Oct. 9, 2017. 


Photo: Courtesy Of Michael Hanrahan

Bradley Wittke photographed the sunset in Pacifica on Oct. 9, 2017. 

Bradley Wittke photographed the sunset in Pacifica on Oct. 9, 2017. 


Photo: Courtesy Of Bradley Wittke

Angelo Bresci photographed the smog shown over San Pablo Bay, south of Petluma on Oct. 9, 2017. 

Angelo Bresci photographed the smog shown over San Pablo Bay, south of Petluma on Oct. 9, 2017. 


Photo: Courtesy Of Angelo Bresci

Carole Schurch photographed the smog over San Francisco. 

Carole Schurch photographed the smog over San Francisco. 


Photo: Courtesy Of Carole Schurch

Elisabeth Lemos photographed the smog over San Francisco on Oct. 9, 2017. 

Elisabeth Lemos photographed the smog over San Francisco on Oct. 9, 2017. 


Photo: Courtesy Of Elisabeth Lemos

Jordan Aylesworth photographed the smog over San Francisco from the Golden Gate Club on Oct. 9, 2017. 

Jordan Aylesworth photographed the smog over San Francisco from the Golden Gate Club on Oct. 9, 2017. 


Photo: Courtesy Of Jordan Aylesworth

Bob Winters photographed the smog shown over San Francisco on Oct. 09, 2017. 

Bob Winters photographed the smog shown over San Francisco on Oct. 09, 2017. 


Photo: Courtesy Of Bob Winters

Jennie photographed the smog over Oakland on Oct. 9, 2017. 

Jennie photographed the smog over Oakland on Oct. 9, 2017. 


Photo: Courtesy Of Jennie

Tim Pori photographed the smog over San Francisco. 

Tim Pori photographed the smog over San Francisco. 


Photo: Courtesy Of Tim Pori

Liz Lawrence photographed the smog over San Francisco on Oct. 09, 2017. 

Liz Lawrence photographed the smog over San Francisco on Oct. 09, 2017. 


Photo: Courtesy Of Liz Lawrence

Patty photographed the sunrise over San Francisco on October 9, 2017.

Patty photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Patty

Ekaterina Stanton photographed the sunrise over Pacific Heights in San Francisco on October 9, 2017.

Ekaterina Stanton photographed the sunrise over Pacific Heights in San Francisco on October 9, 2017.


Photo: Courtesy Of Ekaterina Stanton

Brenda Billings photographed the sunrise near Candlestick Point.

Brenda Billings photographed the sunrise near Candlestick Point.


Photo: Courtesy Of Brenda Billings

The sunrise over San Francisco on October 9, 2017.

The sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Dianna

Alfonso Salcedo photographed the sunrise over San Francisco on October 9, 2017.

Alfonso Salcedo photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Alfonso Salcedo

@masongoes photographed the sunrise over San Francisco on October 9, 2017.

@masongoes photographed the sunrise over San Francisco on October 9, 2017.


Photo: Instagram / Masongoes

Lennaine Moran photographed the sunrise over San Francisco on October 9, 2017.

Lennaine Moran photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Lennaine Moran

@lifes_a_north_beach photographed the sunrise through hazy conditions from North Beach in San Francisco on October 9, 2017.

@lifes_a_north_beach photographed the sunrise through hazy conditions from North Beach in San Francisco on October 9, 2017.


Photo: Instagram / Lifes_a_north_beach

The sunrise from Alamo Square on October 9, 2017.

The sunrise from Alamo Square on October 9, 2017.


Photo: Courtesy Micahel Turon

@meg photographed the smokey and ashy sunrise from the Embarcadero on October 9, 2017.

@meg photographed the smokey and ashy sunrise from the Embarcadero on October 9, 2017.


Photo: Instagram / Meg

Sharie Michalec photographed the sunrise on a ferry heading into San Francisco from the Vallejo terminal.

Sharie Michalec photographed the sunrise on a ferry heading into San Francisco from the Vallejo terminal.


Photo: Courtesy Of Sharie Michalec

Ekaterina Stanton photographed the sunrise over Pacific Heights in San Francisco on October 9, 2017.

Ekaterina Stanton photographed the sunrise over Pacific Heights in San Francisco on October 9, 2017.


Photo: Courtesy Of Ekaterina Stanton

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

@jayslu photographed the smoke in the air causing an extraordinary color display at dawn in Emeryville on October 9, 2017.

@jayslu photographed the smoke in the air causing an extraordinary color display at dawn in Emeryville on October 9, 2017.


Photo: Instagram / Jayslu

Eliza Hart photographed the sunrise over San Francisco on October 9, 2017.

Eliza Hart photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Eliza Hart

 Lisa Surdulescu photographed the sunrise over San Francisco on October 9, 2017.

 Lisa Surdulescu photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Lisa Surdulescu

A blood red sky in San Francisco, Oct. 9, 2017: View of downtown taken from Pacific Heights

A blood red sky in San Francisco, Oct. 9, 2017: View of downtown taken from Pacific Heights


Photo: S.P. Young

Tanish Peelgrane photographed the sunrise in the Outter Richmond on October 9, 2017.

Tanish Peelgrane photographed the sunrise in the Outter Richmond on October 9, 2017.


Photo: Courtesy Of Tanish Peelgrane

Alfonso Salcedo photographed the sunrise over San Francisco on October 9, 2017.

Alfonso Salcedo photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Alfonso Salcedo

The sunrise from San Rafael on October 9, 2017.

The sunrise from San Rafael on October 9, 2017.


Photo: Lynn Gray

Andrei photographed the sunrise over San Francisco on October 9, 2017.

Andrei photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Andrei

 Nick Rozsa photographed the sunrise over St. Hilary’s Church in Tiburon on October 9, 2017.

 Nick Rozsa photographed the sunrise over St. Hilary’s Church in Tiburon on October 9, 2017.


Photo: Courtesy Of Nick Rozsa

28th Balboa at 7:55am October 9, 2017.

28th Balboa at 7:55am October 9, 2017.


Photo: Larisa Kure

The view over San Pablo Bay from San Rafael on Octobe 9, 2017.

The view over San Pablo Bay from San Rafael on Octobe 9, 2017.


Photo: Courtesy Mary Jane O’Brien

Connor Green photographed the sunrise over San Francisco on October 9, 2017. 

Connor Green photographed the sunrise over San Francisco on October 9, 2017. 


Photo: Courtesy Of Connor Green

 Michael Spring photographed the sunrise over San Francisco from Twin Peaks on October 9, 2017.

 Michael Spring photographed the sunrise over San Francisco from Twin Peaks on October 9, 2017.


Photo: Courtesy Of Michael Spring

Michael Spring photographed the sunrise over San Francisco from Twin Peaks on October 9, 2017.

Michael Spring photographed the sunrise over San Francisco from Twin Peaks on October 9, 2017.


Photo: Courtesy Of Michael Spring

Melisa Martin photographed the sunrise on Interstate 280 North on October 9, 2017.

Melisa Martin photographed the sunrise on Interstate 280 North on October 9, 2017.


Photo: Courtesy Of Melisa Martin

Looking up Moraga towards Sutro Tower, about 7 a.m. on October 9, 2017.

Looking up Moraga towards Sutro Tower, about 7 a.m. on October 9, 2017.


Photo: Courtesy Beth Stevens

Krista photographed the sunrise over San Francisco on October 9, 2017. 

Krista photographed the sunrise over San Francisco on October 9, 2017. 


Photo: Courtesy Of Krista

The sunrise over San Rafael on October 9, 2017.  

The sunrise over San Rafael on October 9, 2017.  


Photo: Bill Disbrow/ SFGATE

American Canyon 7:50 a.m. on Oct. 9, 2017

American Canyon 7:50 a.m. on Oct. 9, 2017


Photo: Kristine Boncato

The Bay Bridge is shrouded in haze at sunrise on October 9, 2017.

The Bay Bridge is shrouded in haze at sunrise on October 9, 2017.


Photo: Courtesy Brian Wanueka

With a smoke-filled sky on Oct. 9, 2017, the Golden Gate Bridge wasn’t even visible in San Francisco. 

With a smoke-filled sky on Oct. 9, 2017, the Golden Gate Bridge wasn’t even visible in San Francisco. 


Photo: Amy Graff

The view from Dogpatch in San Francisco on October 9, 2017.

The view from Dogpatch in San Francisco on October 9, 2017.


Photo: Instagram / Sflemz

Smokey sunrise, Petaluma on
October 9, 2017.

Smokey sunrise, Petaluma on
October 9, 2017.


Photo: Hilary Minor

The view from Pacific Heights on October 9, 2017.

The view from Pacific Heights on October 9, 2017.


Photo: Courtesy Richtenbacher Shankshifter Mrazik

The sunrise over Lake Merritt on October 9, 2017.

The sunrise over Lake Merritt on October 9, 2017.


Photo: Courtesy Kimberley O’Keefe

Briggs Donaldson photographed the sunrise over San Francisco on October 9, 2017.

Briggs Donaldson photographed the sunrise over San Francisco on October 9, 2017.


Photo: Courtesy Of Briggs Donaldson

Allison Baca photographed the sunrise over San Francisco on October 9, 2017.  

Allison Baca photographed the sunrise over San Francisco on October 9, 2017.  


Photo: Courtesy Of Allison Baca

Smoke-filled view of San Francisco from Jasper, Oct. 9, 2017

Smoke-filled view of San Francisco from Jasper, Oct. 9, 2017


Photo: Amy Graff

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

The view from Sausalito on October 9, 2017.

The view from Sausalito on October 9, 2017.


Photo: Lynn Augstein

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

 Lynn Augstein photographed the sunrise on Sausalito on October 9, 2017. 

 Lynn Augstein photographed the sunrise on Sausalito on October 9, 2017. 


Photo: Courtesy Of Lynn Augstein

Phil Johnson photograohed the sunrise over Raccoon Strait in Tiburon on October 9, 2017.

Phil Johnson photograohed the sunrise over Raccoon Strait in Tiburon on October 9, 2017.


Photo: Courtesy Of Phil Johnson

Martha White photographed the sunrise over San Rafael on October 9, 2017. 

Martha White photographed the sunrise over San Rafael on October 9, 2017. 


Photo: Courtesy Of Martha White

Lynn Gray photographed the sunrise in the Bay Area on October 9, 2017.

Lynn Gray photographed the sunrise in the Bay Area on October 9, 2017.


Photo: Courtesy Of Lynn Gray

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

Barbara Schnur photographed the sunrise over San Francisco on October 9, 2017.  

Barbara Schnur photographed the sunrise over San Francisco on October 9, 2017.  


Photo: Courtesy Of Barbara Schnur

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.

Views of San Francisco’s skyline are smoke-filled on the morning of Oct. 9 as multiple wildfires burn in Mendocino and Sonoma counties.


Photo: Amy Graff

Sunrise in San Mateo on October 9, 2017.

Sunrise in San Mateo on October 9, 2017.


Photo: Courtesy Jen Smith


The air quality in much of the Bay Area this week has at times been comparable to — or even worse than —Beijing, one of the most notoriously polluted cities in the world, as smoke from the Wine Country wildfires drifts south and settles over the region.

Smoke-choked residents wore masks while biking or walking to work, and even on BART trains and inside offices. Schools kept restless students indoors all day, or canceled classes altogether. A hundred miles from the fires, people showed up in emergency rooms saying they were having trouble breathing.

The brown-hued sunlight, ash falling like snow, and a persistent campfire smell are the obvious signs of heavy pollution. But more concerning are the invisible, noxious particulates carried in the smoke. These microscopic particles are easily inhaled and can make their way deep into the lungs, causing damage to the delicate tissue.

The poor air quality prompted widespread public health advisories, especially directed at people who already have respiratory problems like asthma or emphysema and who can have serious complications from inhaling smoke. People with heart conditions may also be at increased risk of heart attack or stroke from exposure to particulates.

But otherwise healthy people also can suffer. Smoke pollutants can cause eye, nose and throat irritation. If people spend too much time outside, they may start coughing, or develop a headache or overall fatigue.

This model shows the flow of smoke in the Bay Area on Thursday, October 12, 2017.


Media: San Francisco Chronicle

“This is definitely impacting everybody,” said Dr. Thomas Dailey, medical director of pulmonary medicine at Kaiser Santa Clara. “Patients with emphysema and COPD (chronic obstructive pulmonary disease) and asthma are having shortness of breath or other exacerbations. Even patients who don’t have underlying lung conditions are reporting that their chests feel tight and they’re coughing more.”

Hospitals around the Bay Area have reported upticks in people with symptoms like breathing difficulty, severe coughing or tightness in their chest. Solano County alone reported that 23 people sickened by the pollution had been treated in emergency rooms. Dozens of schools around the region have canceled classes for the remainder of the week.

Outdoor exercise is especially ill-advised. When people work out, they breathe faster and usually through their mouth instead of their nose, all of which increases the amount of pollutants they inhale. Many school athletic programs have canceled or postponed games. This weekend, at least four major running events were canceled due to smoke, including a half marathon in San Francisco and a 31-mile ultramarathon in Muir Beach.


Bay Area stores that sell air purifiers and face masks that block pollutants have been overrun. Many places in the North Bay have been sold out of masks for days, though supplies have been donated to many evacuation centers. Cole Hardware in San Francisco sold out of air purifiers about 20 minutes after getting a new shipment Thursday morning, customers said.

The worst conditions have been in the North Bay areas consumed by smoke. But by Thursday afternoon, as 21 blazes raged statewide, air quality in the East Bay, San Francisco and other pockets around the region was also terrible, rivaling a typical afternoon in Beijing, according to Richard Muller, a UC Berkeley physics professor who created a map that compares air-quality levels around the world.

The air-quality index, a number that takes into account several types of pollutants, was hovering around 160 for the Bay Area most of Thursday. A healthy level is 50 or lower, which is typical for the area; the worst level is 500. The air is expected to remain unhealthy for at least the next two days, according to the Bay Area Air Quality Management District.

Public health and air-quality experts advised people to stay inside with doors and windows closed when possible. Those with pre-existing respiratory and heart conditions should wear masks that block small particles when outside.

Sherry Katz of Berkeley, who teaches history at San Francisco State University, has asthma that in the past has been exacerbated by smoky conditions. She’s avoided complications this week, she said, largely because she’s been taking pains to keep out of the smoke.

To avoid going outside, she worked from home several days, until she had to go into the city Thursday to teach. When she smelled smoke in her classroom, she switched to a different building with better air circulation. And she wore a mask all day, even while in front of the class.

“I know smoke is a trigger for my asthma,” Katz said. “It’s a scary feeling when you can’t breathe very well.”

Katz’s husband, Dr. John Balmes, studies the health effects of air pollutants at the Human Exposure Laboratory at UCSF and has special expertise in wildland fire smoke. He’s studied pollution in Beijing too, and the Bay Area’s air this week has reminded him of China’s dirty, dusty skies.

Several days or even a week of smoke exposure probably isn’t going to cause chronic health problems in otherwise healthy people, Balmes said. And even people who have heart or lung problems already are unlikely to suffer lasting damage from the pollution.

Still, inhaling small particles is never good.

“The public health message is: ‘You shouldn’t be out there,’” Balmes said. “Why expose yourself to a toxin if you don’t need to?”

Erin Allday is a San Francisco Chronicle staff writer. Email: eallday@sfchronicle.com Twitter: @erinallday


To protect yourself

Stay inside with doors and windows closed. Do not use air conditioners or heaters that bring in air from the outside.

If you are not home, seek out public spaces like libraries, movie theaters or shopping malls that use recirculated air. Call ahead to make sure they have air filters.

In San Francisco, these libraries have air filters and are open on Friday during the following hours:

San Francisco Main Library, 100 Larkin St., noon to 6 p.m.

Chinatown Branch Library, 1135 Powell St., 1 to 6 p.m.

Mission Bay Branch Library, 960 Fourth St., 1 to 6 p.m.

Glen Park Branch Library, 2825 Diamond St.,
1 to 6 p.m.

If you are outside, limit exertion.

Wear a mask that keeps out small particles. N95 masks are the most common and can be purchased at hardware stores, pharmacies or stores like Walmart.

Seek medical attention if you have difficulty breathing, wheezing, chest pain, nausea or dizziness that is not resolved by going inside or getting away from smoke.

Dangers of smoke exposure

For people with pre-existing respiratory conditions, smoke inhalation can cause a flareup of symptoms that may not respond well to normal medication and other therapy.

Otherwise healthy people can suffer eye, nose and throat irritation, or develop a cough, headache or overall fatigue.

Children may be especially at risk because their lungs are still developing.

Article source: http://www.sfgate.com/health/article/Wine-Country-fires-smoke-fouls-Bay-Area-air-12274314.php

PSA tests aren’t great for diagnosing prostate cancer. Here are some better options in the works

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The PSA test is an imperfect way to screen men for prostate cancer. But until recently, it was seen as the best option available.

The test measures the amount of prostate specific antigen, or PSA, in the blood. This protein is produced in the prostate and tends to spike in men with cancer.

Now, doctors have new tools to help them detect and manage the often-perplexing disease.

“We haven’t had the perfect tests to guide our decisions,” Loeb says. “But we’re making progress. If you’re coming into this now, you’re in a way better situation than you would have been five or 10 years ago.”

The PHI test, which considers total PSA levels along with two specific types of PSA proteins, is more sensitive than the PSA test alone, says Dr. David Penson, chair of urologic surgery at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn. It is most useful for men with PSA levels between 4 and 10 nanograms per milliliter of blood, a gray area where treatment decisions are tricky.

“If I had a PSA of 6, I would definitely want the PHI test,” he says. “If the test suggests I didn’t have cancer, I would feel great about the world.”

The PHI test, approved by the U.S. Food and Drug Administration in 2012, uses a different scale than the PSA test. If your PHI score is below 27, there’s only about a 10% chance that you have cancer, according to the Mayo Clinic. If your score is above 55, there’s about a 50% chance you have cancer.

A 2015 Journal of Urology study of nearly 1,000 men who underwent biopsies for prostate cancer found that about 40% of unnecessary biopsies could have been avoided by simply skipping the procedure in men with a PHI score below 24. Penson notes that some men would want a biopsy even if they had a low PHI score just to be extra sure they didn’t have cancer. But he suspects most men would get enough peace of mind from the score alone.

“A prostate biopsy is not a lot of fun,” he says. “This helps men make an informed decision.”

The 4Kscore is a screening tool that combines a blood test with other information, including a patient’s age, the results from a digital rectal exam, and whether he’s had a previous biopsy that came up negative. Although it is available to doctors, it is not yet FDA-approved to guide treatment decisions.

In studies, the test has effectively predicted which men with slightly elevated PSAs were most likely to develop metastatic cancer. For example, a 2015 study of blood samples collected from more than 12,500 Swedish men found that less than 0.5% of those with PSAs over 4 and a low 4Kscore went on to develop metastatic prostate cancer in the next 20 years, according to the report in European Urology.

Once a biopsy detects cancer, the new tests can also help determine the next step. Doctors can use the PHI score or the 4Kscore to identify the cancers that are most likely to grow and spread, Loeb says. Those cancers require aggressive treatment, but other, less-aggressive ones are better left alone.

This watch-and-wait approach is becoming more popular as doctors try to move away from unnecessary surgeries, she says. Urologists can monitor changes in test results to decide whether it’s time to take action.

The new tests still fall well short of perfection, but they’re definitely an improvement over the simple PSA test, Penson says. Now doctors hoping to spare as many men as possible from needless biopsies without overlooking serious cancers will need to fine-tune their approach.

“Doctors still don’t know how to put the tests to best possible use,” he says.

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MORE IN HEALTHY LIVING

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Article source: http://www.latimes.com/science/healthy-living/la-he-hl-psa-alternatives-20171012-htmlstory.html

Bureaucracy Is Keeping Health Care from Getting Better


Kelvin Murray/Getty Images

In a recent article, Gary Hamel and Michele Zanini detail the toll that growing bureaucracy is taking across industries. Many of those working in the consolidating health care industry will immediately validate several of the authors’ key findings, including:

  • Bureaucracy is growing, not shrinking.
  • Bureaucracy is destroying value in innumerable ways, including slowing problem solving, discouraging innovation, and diverting huge amounts of time into politicking and “working the system.”
  • CEOs are substantially less likely than frontline staff to see bureaucratic barriers in their organizations.

I’ve seen many health care organizations where the clinicians and other frontline staff who actually help patients are subject to increasing numbers of fragmenting directives from above and are forced to devise work-arounds to cope with ineffective problem-solving systems.

What about solutions? Hamel and Zanini declare that there is “no map to disassembling bureaucracy.” I beg to differ.

Insight Center

Great organizations across industries fight bureaucracy by explicitly structuring their leadership systems to connect everyone in the organization to the issues that the front line is encountering every day. They carefully define the roles of each layer of leadership to include supporting the rapid solving of frontline problems and developing those under them to do the same. Designing and actively managing their systems of daily operation (production), management, and improvement with this clear intention to fight the wastes created by bureaucratic behavior becomes the core of their competitive advantage.

Two cornerstones of this approach provide clear examples of how to fight bureaucratic bloat: lean daily management systems and a real-time problem-solving approach to eliminating workplace injuries.

Lean daily management systems were pioneered by Toyota, Honda, and other manufacturers. As John Toussaint, the CEO of Catalysis and the former CEO of ThedaCare, a health system in Wisconsin, explains, such systems, when designed and operated effectively, ensure that every leader has explicit work that they must do every day to help understand frontline problems and improvement opportunities. Lean daily management makes top-level goals and strategies very clear and present for everyone in the organization and ensures that leaders’ efforts help, rather than hinder, the frontline work necessary to meet those goals.

Real-time safety learning provides a complementary antidote to bureaucratic bloat. At Alcoa, DuPont, and other world leaders in safety, any injury is reported all the way up to the CEO, investigations and solutions are reported within 48 hours, and all of this information is shared with everyone in the company every day. For leaders, this provides a daily, concrete, values-centered indication of whether the organization is effectively learning and solving frontline problems, or whether those signals are being blocked and why. It has proven to be a great mechanism for improving operations as a whole, because it forces the bureaucracy to support, rather than impede, the rapid breaking of barriers, problem solving, and frontline learning and empowerment.

Happily, a number of pioneering health care organizations are using these approaches to successfully combat the detrimental effects of bloat. To cite just a few examples:

ThedaCare pioneered lean daily management to protect and extend care model innovations that improved quality and reduced the cost of care by 30%.

At the University of Virginia Health System, the CEO leads a huddle every day in which the health system leaders and a “slice” of each part of the organization review the unexpected deaths of patients and every injury due to incidents, such as medication errors or falls, that occurred during the previous 24 hours. This huddle team also assesses the strength of the problem solving and how effectively warnings and learning are being shared across the health system. Its members will often visit one of the clinical units where an incident has occurred, concretely demonstrating to the staff the importance they place on rapidly learning from incidents.

In the Minneapolis–St. Paul metropolitan area, the Fairview and HealthEast health systems recently agreed to merge. They’re doing so not just because the deal makes geographic sense in a consolidating market but also because both systems’ CEOs are committed to using lean management to achieve goals.

It’s easy for organizations to start using these techniques. One simple approach is for leaders to have an internal or external adviser versed in these methods to guide them in directly observing frontline work. Within 20 minutes leaders will see things that they haven’t learned in years of meetings. Some of it will be exciting: Their people have the motivation and talent to delight patients. Some will be upsetting but instructive: One executive saw a nurse hunt for an IV pump for his patient for more than 20 minutes. Another discovered that hot water had not been available in several intensive care units for several days because bureaucratic barriers rooted in budget issues and politics were inhibiting departments from working together to fix the problem.

Bureaucracy is destroying more and more value in many health care systems, but it doesn’t have to be that way. There are proven ways to fight back. They entail consciously designing your management systems to liberate the capabilities of all employees so that they can be used to address patients’ needs.

Article source: https://hbr.org/2017/10/bureaucracy-is-keeping-health-care-from-getting-better

A Lost Year For OPKO Health

2017 has been a tough year for OPKO Health (OPK). The stock is down more than 25% year to date, significantly underperforming the general market and its biotech peers. Looking at the chart, a bystander could have concluded that OPKO’s commercial business is imploding and that its pipeline is failing. This is certainly not the case – instead, OPKO is a victim of the expectations game. Rarely does a stock perform well when expectations are falling. And, while I believe OPKO is certainly worth much more than the current share price implies, the company has done little to make investors excited over the last 12 months:

  • hGH-CTP failed in the phase 3 trial in adults. This is a minor setback for the company as the adult segment accounts for approximately 20% of the total market, but investors punished the stock, and this event marked the start of a decline from which the company is yet to recover.
  • The diagnostics business is under pressure. More on this later.
  • Rayaldee is having a slow launch. I warned about the possibility of a slow launch and expected it, but am still slightly disappointed with the results in the first six months of the launch.
  • Partner Tesaro (NASDAQ:TSRO) received a CRL from the FDA for the IV version of its CINV drug Varubi.

And the good news over the last 12 months – CEO Frost was buying shares almost every day, and other insiders have bought occasionally, and that’s it (a vote of confidence in the company). It is hard to expect a stock to move higher when nothing positive is happening. You might wonder why I am bullish on OPKO after this kind of an introduction, but it is because I am taking a longer-term view. Investor sentiment is negative, and I am obviously not excited about the near-term prospects either, but OPKO is a company with a solid diagnostics business, it has approved drugs (Rayaldee and Tesaro’s Varubi, where it is receiving royalties on net sales) and a very broad pipeline which should produce at least a few commercial products in the next 4-5 years. I remain an OPKO bull, and while I don’t expect the stock to outperform in the near term, I do expect it to deliver strong long-term gains.

Expectations still dropping – when will we see a turnaround?

As mentioned in the introduction, OPKO’s share price is a victim of the expectations cycle. Rarely do stocks perform well when expectations are dropping, and OPKO is no different. The underperformance of the diagnostics business, the hGH-CTP phase 3 setback, Rayaldee’s slow launch and Tesaro receiving a CRL for the IV version of its CINV drug Varubi have all weighed on OPKO’s share price. But overall, these aren’t major or thesis-killing setbacks.

The company is not giving up on hGH-CTP in adults and may submit a BLA (though I remain skeptical about chances of approval), but this is a minor part of the growth hormone deficiency market. The pediatric market accounts for roughly 80% of the total market, and the phase 3 trial is ongoing with a data readout expected in 1H 2019. Unlike the adult trial, where the primary endpoint was the change of trunk fat mass from baseline at 26 weeks, the primary endpoint in the pediatric trial is annual height velocity after 12 months of treatment. hGH-CTP demonstrated strong results in the phase 2 trial which should be replicated in the phase 3 trial. hGH-CTP performed well even in the phase 3 trial in adults, but according to OPKO, the outliers in the placebo group affected the results. The pediatric phase 3 study will compare hGH-CTP to Genotropin, the same as in phase 2, and we are unlikely to have outliers in this trial like we did in the adult trial – one can lose trunk fat mass excessively due to exercise, but a child cannot achieve greater height through an effort of its own.

The growth hormone deficiency market is a $3 billion and growing global market. Compliance remains an issue, and having a drug dosed once a week instead of every day should improve compliance and accelerate the growth of this market. However, it is worth noting that OPKO is not alone in racing its solution to the market. Other competitors are looking to get their own long-acting versions to the market as well. Partner Pfizer should be of great help with the marketing efforts if/once hGH-CTP is approved. OPKO is entitled to receive royalties on net sales between high teens and mid-20s in the adult population and to an undisclosed, tiered geographical gross profit split for both hGH-CTP and Genotropin if/when approved for pediatric patients. OPKO is also entitled to receive up to $275 million in additional regulatory milestone payments. Overall, this is a potentially very lucrative product for Pfizer and OPKO.

But I digress. I was talking about expectations. Another setback was partner Tesaro receiving a CRL for the IV version of Varubi. Getting the IV version approved is very important as the CINV market is dominated by IV drugs. Tesaro is expected to take market share away from Emend, and so is Heron’s (HRTX) Cinvanti (pending FDA approval in November). The NK-1 products are underutilized, and the launches of these two drugs should help expand this market along with them eating Emend’s share of the market.

Source: Heron presentation

OPKO is entitled to receive low double-digit to low-20s royalties based on specified (but undisclosed) sales levels and up to $85 million in milestones. I expect Varubi to be approved this month and its uptake to be solid in the following years. Unlike the hGH-CTP setback in the adult population and its positive resolution being uncertain, I think there is no significant uncertainty here and that this was just a temporary setback. And, I have confidence in Tesaro’s execution capabilities as it has already captured significant market share in the oral NK-1 market, which is not very large.

Moving on to Rayaldee. As covered in previous articles, I did not expect much from Rayaldee in 2017 but am slightly disappointed with the uptake since launch. The company noted that total prescriptions grew 140% in Q2 compared to Q1, and though the growth looks impressive at first glance, it comes off a very low base in Q1 (600-650 prescriptions in Q1 and approximately 1,500 prescriptions in Q2). But the lack of meaningful growth is a consequence of a limited sales effort and modest coverage, and both should improve significantly heading into 2018.

Rayaldee began 2017 with slightly more than 40% lives covered and coverage rose to 68% at the end of June. The company expects to exit 2017 with more than 70% of lives covered. OPKO also expects to expand the sales force from 35 reps and 5 regional managers to 70 reps and 7 regional managers by October. These efforts should help accelerate growth in 2018. Partner Vifor also expects to submit an MAA in the EU in 1H 2018 and to launch Rayaldee in Europe in 2019. Unlike OPKO, Vifor has an established and strong presence in markets where it intends to market Rayaldee, and I expect Vifor to do better with Rayaldee than OPKO. Additional growth from Rayaldee could come from label expansion – OPKO expects to start a phase 2 trial for Stage 5 CKD patients with SHPT undergoing dialysis during Q4 2017.

And, finally, a word on the diagnostics business. The company is still in the midst of a revenue cycle management program, and management said it is seeing improvements in collection rates beginning in March and it also expects to see some acceleration in the second half of the year. These trends should help improve the profitability of the business in the following quarters. However, these improvements were offset by pricing headwinds in the genomics business, which drove a decrease in services revenue despite increased volumes. Management believes these price decreases have now stabilized and that revenues from services should start to reflect the expected volume increases. Based on these comments, we should start seeing a turnaround in the diagnostics business in the following quarters.

The 4Kscore was flat in Q2 compared to Q1, but up 58% in 1H 2017 compared to 1H 2016, and OPKO is looking to reinvigorate its growth with a direct-to-consumer campaign.

Source: OPKO presentation

With these setbacks and latest developments in mind, I think there is a good chance for us to see the expectations cycle turn around in the following quarters, based on the following:

  • The diagnostics business should return to growth in the second half of the year.
  • 4Kscore test growth should accelerate based on increased marketing efforts. Negative coverage determination by Palmetto last year remains an overhang, but the test is getting reimbursed in 98% of cases by Novitas, and the company is doing some clinical work to address the issues raised by Palmetto last year.
  • Claros 1 should be launched in 2018, helping improve the growth of this business segment.
  • OPKO is still not recording Rayaldee revenues. The company expects to start recording revenues by Q4 2017 or in Q1 2018. Not that there was much revenue to record until now. The increased sales force and significantly improved coverage positions Rayaldee for stronger growth in 2018.
  • Tesaro should have Varubi IV approved by the end of October and launch by the end of 2017. OPKO should start collecting more meaningful royalties in 2018.
  • OPKO will meet with the FDA to discuss the phase 3 results of hGH-CTP in adults. BLA submission could be a minor catalyst for the stock.
  • Rayaldee’s approval and launch in the EU by partner Vifor in 2019 is a longer-term catalyst but one that should result in regulatory milestones and royalties on net sales.
  • Factor VIIa-CTP phase 2a dose-escalation study is ongoing and nearing completion. We should see data from this trial in the not too distant future.

Additionally, OPKO has a broad pipeline with several phase 2 trials slated to start in the following months:

  • Rayaldee – phase 2 trial for Stage 5 CKD patients with SHPT undergoing dialysis to start in Q4 2017.
  • OPK88004 – SARM, phase 2b trial in men with benign prostate hyperplasia (BPH or enlarged prostate) to start in Q4 2017.
  • OPK88003 – oxyntomodulin to start a phase 2b dose-escalation study in type 2 diabetes patients in 1H 2018.
  • OPK88002 – NK-1 antagonist to treat pruritus (severe itching) in Stage 5 CKD patients undergoing dialysis. Phase 2a trial should start in Q4 2017.
  • OPK88001 – an oligonucleotide-based AntagoNAT for the treatment of Dravet Syndrome. Phase 2 trial should start in Q4 2017.

As mentioned earlier, the phase 3 trial of hGH-CTP is progressing with results expected in 1H 2019.

And, finally, we should not forget that OPKO is a very acquisitive company, and we might see more MA in the following years, which should further expand the company’s pipeline.

Near-term catalysts

Potential near-term catalysts include:

  • Q3 report showing improved revenue generation from the diagnostics business.
  • Acceleration of 4Kscore’s growth in the following quarters.
  • Clarity on the hGH-CTP adult program and/or a BLA submission.
  • Varubi IV PDUFA date, October 25.
  • Factor VIIa-CTP phase 2a trial results (timing not specified, but possibly in the next six months).

These catalysts are at the same time the main risks in the near term – continued poor performance of the diagnostics business, 4Kscore not growing, FDA requesting a new adult trial for hGH-CTP, FDA issuing another CRL for Varubi IV and Factor VIIa-CTP reporting poor phase 2 results.

Conclusion

OPKO may not be out of the woods yet, but I think the situation should start to improve in the following quarters. The diagnostics business should turn around, and Rayaldee’s growth should accelerate as the sales force and coverage expand. OPKO also plans to start several phase 2 trials in the following months and data readouts over the next 2-3 years should help increase shareholder value along with the progress of the commercial portfolio. We also shouldn’t neglect potential MA as OPKO has been very acquisitive in the past. The company is in good financial shape with $130 million in cash and equivalents at the end of Q2 and is almost cash-flow breakeven.

Author’s note: Growth Stock Forum subscribers had an early look at an expanded version of this article on September 7, and have access to regular exclusive updates on every stock I am covering.

Disclosure: I am/we are long OPK, HRTX.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: This article reflects the author’s personal opinion and should not be regarded as a buy or sell recommendation or investment advice in any way.

Article source: https://seekingalpha.com/article/4113104-lost-year-opko-health

In Cities, It’s the Smoke, Not the Fire, That Will Get You

No one knows what sparked the violent fires ablaze in the hills of California wine country. In the last five days, the flames have torched more than 160,000 acres across Napa and Sonoma counties, reducing parts of Santa Rosa to piles of cinder and ash and leaving more than 20 dead and hundreds missing. And far from the white-hot embers of destruction, residents from San Francisco to Sacramento to Fresno have been waking up this week to choking fumes, commuting to work under skies tinged orange with dust and soot.

Now, in just a single fire season, ash has rained down on Portland, Seattle, San Francisco, and Los Angeles. That might seem like an anomaly—but it’s more a portent of the country’s new, char-coated normal. As climate-change fuels increasingly large and frequent wildfires that hit closer and closer to densely populated urban centers, the smoke they produce is becoming a public health crisis.

“Over the past two days we’ve experienced unprecedented levels of air pollution in the region,” says Kristine Roselius, a spokeswoman for the Bay Area Quality Management District. Things cleared up slightly on Wednesday, but mercurial weather patterns make it hard to know if the worst is still yet to come. “It’s very difficult to forecast what the air quality will be at any moment because we’ve still got active fires.”

But in general, the forecast is not good. Roselius says they’re especially concerned about the elevated levels of PM2.5—very small bits of liquids and solids suspended in the air, no bigger than 2.5 micrometers across. Particles this small can be inhaled into the deepest recesses of the lungs, into the broccoli-shaped alveolar sacs, where they bypass the body’s filtration systems and slip directly into the bloodstream. What exactly is in those tiny droplets and specks depends on the source, the season, and atmospheric conditions. But it’s the amount of particulate matter more than the type that matters for health.

Good clean air will have fewer than a dozen micrograms of PM2.5′s per cubic meter of atmosphere. Most people won’t notice anything up to about 55 micrograms, but folks with heart or lung disease will likely experience shortness of breath, wheezing, coughing, and chest pain. Asthma sufferers will become more prone to attacks. And as PM2.5 concentrations rise above 55 µg/m3, anyone working or exercising outside will start to notice.

Breathing will start to feel more difficult, and you might get light-headed. Children get hit harder, since they breathe faster than adults. Beyond 100 µg/m3 even healthy adults just walking around will start feeling a sting in their eyeballs and at the back of their throats, chest tightness, and the need to cough. Air monitors near the WIRED offices, 50 miles from the fires, were reading out 137 µg/m3 on Wednesday, and the mucous membrane burn was quite noticeable indeed. Symptoms like these will go away when air quality improves. But breathing in a lot of PM2.5’s can lead to serious long-term health problems.

So first things first: protection. Public health officials like Roselius are advising people with chronic respiratory illness to seek filtered air, either in the city or outside the region. That means buildings with high efficiency mechanical or electronic air cleaners, like these public libraries in San Francisco. If you’ve got air conditioning at home, set it to recirculate mode and make sure all your doors and windows are tightly closed. Three out of five households in California report having air conditioning, although most of these are in the southern parts of the state. Karl the Fog provides all the air conditioning the Bay Area has ever really needed. Good for the energy grid. Bad for those seeking a smoke-free haven.

As for facewear, a bandana worn around the mouth won’t do anything but making you feel like an outlaw. One-strap paper masks or surgical masks won’t help you either. Your best bet: disposable respirators, like the ones found at hardware stores and pharmacies. Look for ones labeled N95 and make sure they’re properly sealed around your face (that goes double for San Francisco’s bearded hipsters).

But the best thing to do is limit your time outside as much as possible. And don’t exert yourself any more than you have to. Because while it’s hard for scientists to predict how bad air quality will be in the aftermath of a wildfire, it’s even harder for them to predict the long-term public health impacts.

    More on Wildfires

  • The Napa Fire Is a Perfectly Normal Apocalypse

  • The Science of Fighting Wildfires Gets a Satellite Boost

  • The West Is on Fire. Blame the Housing Crisis

Over the years, researchers have tried unsuccessfully to measure the full health effects of wildfire smoke. The general consensus, based on hospital records, is that more smoke means more trips to the doctor for things like asthma, pneumonia, bronchitis, COPD, and heart failure. Children, the elderly, women, African Americans, and those with underlying chronic diseases appear to be most susceptible. But it’s been tricky to prove causation, because air pollution comes from so many places—wildfires, yes, but also tailpipes and factories.

That’s one of the reasons the Environmental Protection Agency just launched a crowd-sourced study to understand the link between wildfire smoke and health impacts. Using an app called SmokeSense, anyone can now send the EPA a snapshot of the air quality in their zip code, report nearby smoke or fire, and list symptoms they’re experiencing.

It’s work that’s increasingly important as more acres of American forests go up in smoke each year. “As the climate continues to change, we’re going to see much more smoke, at higher intensities in the future,” says Jia Coco Liu, an environmental health researcher at Johns Hopkins. Based on air pollution from past and projected future wildfires in the American West, Liu and a team of scientists at Yale estimated that by mid-century more than 82 million people will experience smoke waves—more than two consecutive days with high levels of wildfire-related air pollution. People in the new Smoke Belt—Northern California, Western Oregon, and the Great Plains—are likely to suffer the highest exposure.

And there’s one more bit of bad news: Just as fire behaves differently in a city than it does out in the wild, so does smoke. Urban areas, with their concrete roads and walls of glass and steel, tend to stop a fire in its tracks. All those buildings and alleyways prevent wind from blowing fresh embers around. But those same aerodynamics mean that smoke gets trapped in cities. Liu’s latest research, which will appear in an upcoming issue of the American Journal of Epidemiology, found that metropolitan areas, even ones very far away from any actual wildfires, had much higher levels of particulate matter in the air than rural areas. An urban smoke island effect, if you will.

By looking at Medicare billing information, Liu was able to see a corresponding uptick in respiratory and other health issues. She hopes the research will help raise awareness that wildfire smoke is more than a nuisance. “People think of wildfires and they think about houses burning down,” she says. “From the city it can feel like a faraway problem. But actually, it’s the smoke that has a much higher impact.”

Article source: https://www.wired.com/story/smoke-from-wildfires-is-a-growing-public-health-crisis-for-cities/