Zika’s here. What’s next? – Politico

A cure for Alzheimer’s is Hillary Clinton’s “moonshot,” per a top adviser, and the two candidates for a Senate seat agree that one addiction ad goes too far. But first: The latest on Zika virus in South Florida.

ZIKA VIRUS. It’s here. It’s spreading. So what happens next? Monday’s confirmation that mosquitoes in Miami have now infected 14 residents with Zika virus led to a series of fast-acting emergency responses.

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Gov. Rick Scott — no fan of the federal government — asked for more preparedness help, and the CDC responded by sending eight experts to Miami to work on lab testing, vector control, and Zika prevention for pregnant women.

CDC also warned pregnant women against travel to the Miami neighborhood that’s the epicenter of the Zika outbreak — the first time it’s advised against visiting any area of the continental United States.

Two things that haven’t changed: Congress remains on recess, and there’s still no Zika funding package. However, Sen. Marco Rubio joined a number of Democrats on Monday in calling for Congress to reconvene and pass a funding package to fight the virus.

“Congress should come back immediately, and pass the President’s plan without further delay, equivocation, cuts to other health programs, or political riders,” Ron Klain, who oversaw the Obama administration’s Ebola response, told PULSE.

Why the CDC told pregnant women to avoid just a tiny sliver of Miami. It turns out the Zika mosquito only travels about 150-square-meters in its lifetime, according to CDC officials, so it bites and infects people in a small geographic area. It also thrives in dense, populated areas — and that’s why CDC told pregnant women to avoid just one-square-mile of Miami, an area north of downtown that includes the Wynwood neighborhood.

Zika’s a “focal” problem, CDC Director Tom Frieden told reporters on Monday. That makes it quite different from the West Nile virus, which was carried by both infected birds and mosquitoes and made the transmission possible over much longer distances.

THIS IS TUESDAY PULSE — Where we’re trying to settle an office debate: Would you rather eradicate all the mosquitoes on Earth, or every cockroach? Bug us with answers and tips at ddiamond@politico.com or @ddiamond on Twitter.

With help from Nancy Cook (@nancook), Rachana Pradhan (@rachanadixit), Sarah Karlin-Smith (@SarahKarlin) and Darius Tahir (@dariustahir).

ON THE TRAIL

For Hillary Clinton, ‘Alzheimer’s is her moonshot.That’s according to Ann O’Leary, who’s serving as Clinton’s senior health adviser. O’Leary told Richard Harris of Next Avenue and Forbes that the Democratic nominee will make an Alzheimer’s cure “one of the biggest issues” of her presidential run.

“Vice President Biden’s moonshot is cancer, which she fully supports, but Secretary Clinton plans to invest $20 billion over the next decade to find an effective treatment for Alzheimer’s,” O’Leary said. More: http://bit.ly/2anqrea

Clinton’s Zika plan stems from Chelsea’s advocacy. The Democratic nominee’s daughter read about Zika in the New York Times last year and — three months pregnant at the time — urged her mom to come up with a detailed policy position, Julia Ioffe and Annie Karni report for POLITICO Magazine: http://politi.co/2aehUgl

Obama agencies bet on Clinton win. A number of agencies, including HHS, are pumping out rules that won’t take effect until next year. But what happens to MACRA and more if Donald Trump takes office? More from Pro’s Andrew Restuccia: http://politico.pro/2atTs9B

Jill Stein backs off backing off anti-vaccine rhetoric. Shortly after the Green Party candidate disavowed a link between vaccines and autism — as reported in yesterday’s PULSE — Stein deleted her original tweet and replaced it with a more equivocal stance.

— Stein’s original tweet: “There’s no evidence linking autism with vaccines.”
— Stein’s replacement tweet: “I’m not aware of evidence linking autism with vaccines.”

Stein isn’t aware of evidence linking autism and vaccines because there is no evidence of a link.

AROUND THE NATION

Both candidates for N.H. Senate seat want heroin attack ad pulled. The National Republican Senatorial Committee has posted a new ad that blasts Gov. Maggie Hassan for failing to lead the state’s fight again heroin addiction — and her rival Sen. Kelly Ayotte says it goes too far.

“I’ve said it before and I’ll say it again: no one should play politics with the heroin epidemic, and this ad should be taken down,” Ayotte said in a statement.

Hassan’s campaign fired back that Ayotte’s rebuke doesn’t go far enough. “Ayotte’s words are hollow unless she pledges not to raise or accept funds from her Washington Republican colleagues who are running this offensive ad,” a Hassan campaign official said.

Ohio Democrats say Portman is ‘hypocritical’ for taking CARA credit. Sen. Rob Portman is touting his support of the Comprehensive Addiction and Recovery Act — despite voting down crucial funding for the law, Democrats say.

Portman is currently on a seven-city tour, touting how CARA will reduce heroin and prescription drug overdoses across Ohio. He also gave this weekend’s Republican weekly address on the law’s national impact too.

But Democrats say the law — which was funded at about 20 percent of the White House’s request — lacks crucial resources, because Republicans like Portman voted against funding it.

“Portman can’t escape his own hypocritical record,” Daniel van Hoogstraten of the Ohio Democratic Party said. “He proposed slashing hundreds of millions from drug abuse prevention programs, voted to cut millions more in Congress — and Portman actually voted against funding for the very same bill he’s bragging about.”

** A message from PhRMA: Rhys’ diagnosis isn’t his destiny. But as a five year old with type 1 diabetes, he is thriving thanks in large part to medicines developed by biopharmaceutical companies. With 180 medicines in development for diabetes, Rhys has hope for an even brighter future. Learn more at here. **

EYE ON THE HUMPHREY BUILDING

CMS announces 14 regions for Comprehensive Primary Care Plus initiative. CMS announced that 14 regions will participate in its new Comprehensive Primary Care Plus initiative, a five-year model designed to reform primary care delivery across public programs and commercial insurance.

The agency, which originally wanted to implement the model in as many as 20 regions, selected the regions based on insurer interest and coverage. Those regions include:

— Arkansas, Colorado, Hawaii, the greater Kansas City region, Michigan, Montana, New Jersey, the North Hudson-Capital region in New York, Ohio, Oklahoma, Oregon, the greater Philadelphia region, Rhode Island and Tennessee.

CMS also released a list of participating commercial insurers and state Medicaid agencies.

… Nearly 70 insurers/state Medicaid agencies have agreed to participate in the model, Pro’s Rachana Pradhan reports. And many insurers that participated in the initial Comprehensive Primary Care program — which launched in 2012 — are involved in the new initiative, but not all. For example, Aetna isn’t doing CPC+ in Colorado and New York; Cigna isn’t in Colorado either. AmeriHealth New Jersey isn’t in that state. Regence Blue Cross Blue Shield declined to participate in Oregon.

Grassley says he hasn’t gotten HHS Zika breakdown. Sen. Chuck Grassley, who asked HHS in early July to lay out its Zika spending by last Friday, says he still doesn’t have a response. Grassley on Monday said that the agency told his staff that they’re working on a response. Grassley said: “The taxpayers have the right to expect that these agencies are ready to protect all of us from public health threats.”

EYE ON INSURANCE MARKETS

Fewer small employers now offer health coverage. That’s according to new research from the Employee Benefit Research Institute, which finds that the rate of small employers who offer health insurance has been falling since 2009 — with the biggest decrease among employers with fewer than 10 workers.

… The number of businesses with fewer than 10 employees that offer health insurance fell from 35.6 percent in 2008 to 22.7 percent in 2015, Pro’s Nancy Cook reports.

Meanwhile, the second biggest drop was found with employers with anywhere from 10 to 24 workers — but the number of large employers (with anywhere from 100 to more than 1,000 employees) continued to offer health insurance at a steady rate.

According to EBRI, the decrease in small employer health coverage can be chalked up to several factors, like rising health care costs, attitudes toward the ACA, fears of rising costs, the global financial recession, and the availability of non-group insurance in the public exchange. Read more on the research here: http://bit.ly/2aKKirh

EYE ON PHARMA

There’s evidence biosimilars can be interchangeable. That’s according to a new review in the Annals of Internal Medicine, which looks at evidence across 20 studies for drugs to treat inflammatory disease like rheumatoid arthritis and inflammatory bowel disease.

The five Phase III trials reviewed suggest similar clinical response for the biologics as well as adverse events. Further, four studies that had patients switching between the brand and biosimilar versions demonstrated similar safety and efficacy outcomes, Pro’s Sarah Karlin-Smith reports.

… The study comes as many of these medicines, which take in billions each year, are poised to face FDA-approved biosimilars, including AbbVie’s Humira, Amgen’s Enbrel, and Johnson & Johnson’s Remicade.

FDA hasn’t yet said how a biosimilar could get an interchangeable designation, which would permit automatic substitution by a pharmacy. But patient and doctors’ groups have already raised concerns about the safety of switching patients to the cheaper biosimilar medicines. http://bit.ly/2avo8oo

THERANOS

New look, new product — same old evasiveness. Facing a tough crowd at the American Academy for Clinical Chemistry meeting, Elizabeth Holmes didn’t reveal any long-awaited data about Theranos’ existing tests — and instead debuted a brand-new product.

Holmes unveiled a device called the “miniLab,” a cube-like box that’s intended to be comparable to traditional lab devices, Pro’s Darius Tahir reports. At any rate, the device is not the “Edison” machines that caused the company, regulators, and the public so much grief. Some scientists cried foul, with one calling it a “bait-and-switch.”

However, the company says that validation from FDA and peer-reviewed tests are around the corner.

WHAT WE’RE READING by Brianna Ehley

The New York Times looks at cell therapy, the aggressive new treatment cancer researchers are hoping to bring to market soon that is supposed to “turbocharge the immune system” to fight certain types of cancer: http://nyti.ms/2aEGkxP

A new lawsuit alleges that Celgene engaged in a “scheme” that involved donating hundreds of millions of dollars to charities that help patients afford specialty drugs for certain types of cancers in order to make money, Bloomberg reports: http://bloom.bg/2aYG77B

Some hospital ICU units are lifting strict visitor restrictions after research has revealed that patients fare better having more people visit them, the Wall Street Journal reports: http://on.wsj.com/2avuc0c

Pennsylvania hospitals provide just a tiny fraction of charity care compared to other states, the Pittsburgh Post-Gazette reports: http://bit.ly/2am6ch1

Despite dentists’ persistence to always remember to floss, there is little research to prove its effectiveness, the Chicago Tribune writes: http://trib.in/2aqMnDa

** A message from PhRMA: In 2001, Jamie was diagnosed with a rare blood cancer and worried she wouldn’t get to see her son grow up. But thanks to new targeted therapies developed by America’s biopharmaceutical companies, Jamie continues her courageous fight. Each step brings us closer to a cure. Learn more here. **

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